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NCT03101293	9.4	Biological Sample Retention and Destruction	9.4 Biological Sample Retention and Destruction In this study, specimens for genome/gene analysis will be collected as described in Section [9.1.12.](#page-43-2) The genetic material will be extracted, purified, and initially stored at Covance Central Laboratory and then preserved and retained at Covance Biorepository ...	[]
NCT03101293	9.5	Blood Volume	9.5 Blood Volume Approximate blood volumes to be collected for each subject are shown in [Table 9.f.](#page-48-1) Table 9.f Approximate Blood Volume \| \| \| \| Number of Samples (a) \| \| \| \| \| \| \| \| \| \| \|--------------------------------------------------\|--------\|-----------\|-----------------------\|-----\|-----\|-----\|------...	[]
NCT03101293	10.0	PRETREATMENT EVENTS AND ADVERSE EVENTS	10.0 PRETREATMENT EVENTS AND ADVERSE EVENTS	[]
NCT03101293	10.1	Definitions	10.1 Definitions	[]
NCT03101293	10.1.1	PTEs	10.1.1 PTEs A PTE is defined as any untoward medical occurrence in a clinical investigation subject who has signed informed consent to participate in a study but prior to administration of any study drug; it does not necessarily have to have a causal relationship with study participation.	[]
NCT03101293	10.1.2	AEs	10.1.2 AEs An AE is defined as any untoward medical occurrence in a clinical investigation subject administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory value), sym...	[]
NCT03101293	10.1.3	Additional Points to Consider for PTEs and AEs	10.1.3 Additional Points to Consider for PTEs and AEs An untoward finding generally may: - Indicate a new diagnosis or unexpected worsening of a pre-existing condition. (Intermittent events for pre-existing conditions or underlying disease should not be considered PTEs or AEs.) - Necessitate therapeutic intervention. -...	[ "Pre-existing conditions:", "Worsening of PTEs or AEs:", "Changes in intensity of AEs/Serious PTEs:", "Preplanned surgeries or procedures:", "Elective surgeries or procedures:", "Overdose:" ]
NCT03101293	10.1.4	SAEs	10.1.4 SAEs An SAE is defined as any untoward medical occurrence that at any dose: - 1. Results in DEATH. - 2. Is LIFE THREATENING. - The term "life threatening" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused dea...	[]
NCT03101293	10.1.5	Intensity of PTEs and AEs	10.1.5 Intensity of PTEs and AEs The different categories of intensity (severity) are characterized as follows: Mild: The event is transient and easily tolerated by the subject. Moderate: The event causes the subject discomfort and interrupts the subject's usual activities. Severe: The event causes considerable interfe...	[]
NCT03101293	10.1.6	Relationship of AEs to Study Drug	10.1.6 Relationship of AEs to Study Drug The relationship of each AE to study drug will be assessed using the following categories: Related: An AE that follows a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which possible involvement of the drug ...	[]
NCT03101293	10.1.7	Relationship to Study Procedures	10.1.7 Relationship to Study Procedures Relationship (causality) to study procedures should be determined for all PTEs and AEs. The relationship should be assessed as Related if the investigator considers that there is reasonable possibility that an event is due to a study procedure. Otherwise, the relationship should ...	[]
NCT03101293	10.1.8	Start Date	10.1.8 Start Date The start date of the AE/PTE is the date that the first signs/symptoms were noted by the subject and/or investigator.	[]
NCT03101293	10.1.9	Stop Date	10.1.9 Stop Date The stop date of the AE/PTE is the date at which the subject recovered, the event resolved but with sequelae, or the subject died.	[]
NCT03101293	10.1.10	Frequency	10.1.10 Frequency Episodic AEs/PTE (eg, vomiting) or those which occur repeatedly over a period of consecutive days are intermittent. All other events are continuous.	[]
NCT03101293	10.1.11	Action Concerning Study Drug	10.1.11 Action Concerning Study Drug - Drug withdrawn a study drug is stopped because of the particular AE. - Dose not changed the particular AE did not require stopping a study drug. - Unknown only to be used if it has not been possible to determine what action has been taken. - Not Applicable a study drug was stopped...	[]
NCT03101293	10.1.12	Outcome	10.1.12 Outcome - Recovered/resolved the subject returned to first assessment status with respect to the AE/PTE. - Recovering/resolving the intensity is lowered by 1 or more stages: the diagnosis or signs/symptoms has almost disappeared; the abnormal laboratory value improved, but has not returned to the normal range o...	[]
NCT03101293	10.2	Procedures	10.2 Procedures	[]
NCT03101293	10.2.1	Collection and Reporting of AEs	10.2.1 Collection and Reporting of AEs	[]
NCT03101293	10.2.1.1	PTE and AE Collection Period	10.2.1.1 PTE and AE Collection Period Collection of PTEs will commence from the time the subject signs the informed consent to participate in the study and continue until the subject is first administered study drug (Day 1 of Period 1) or until screen failure. For subjects who discontinue prior to study drug administra...	[]
NCT03101293	10.2.1.2	PTE and AE Reporting	10.2.1.2 PTE and AE Reporting At each study visit, the investigator will assess whether any subjective AEs have occurred. A neutral question, such as "How have you been feeling since your last visit?" may be asked. Subjects may report AEs occurring at any other time during the study. Subjects experiencing a serious PTE...	[ "CONFIDENTIAL" ]
NCT03101293	10.2.2	Collection and Reporting of SAEs	10.2.2 Collection and Reporting of SAEs When an SAE occurs through the AE collection period it should be reported according to the following procedure: A Takeda SAE form must be completed, in English, and signed by the investigator immediately or within 24 hours of first onset or notification of the event. The informat...	[]
NCT03101293	10.2.3	Reporting of Abnormal LFTs	10.2.3 Reporting of Abnormal LFTs If a subject is noted to have ALT or AST elevated >3×ULN on 2 consecutive occasions, the abnormality should be recorded as an AE. In addition, an LFT Increases page of the eCRF must be completed providing additional information on relevant recent history, risk factors, clinical signs a...	[]
NCT03101293	10.3	Follow-up of SAEs	10.3 Follow-up of SAEs If information is not available at the time of the first report becomes available at a later date, the investigator should complete a follow-up SAE form or provide other written documentation and fax it immediately within 24 hours of receipt. Copies of any relevant data from the hospital notes (e...	[]
NCT03101293	10.3.1	Safety Reporting to Investigators, IRBs, and Regulatory Authorities	10.3.1 Safety Reporting to Investigators, IRBs, and Regulatory Authorities The sponsor will be responsible for reporting all suspected unexpected serious adverse reactions (SUSARs) and any other applicable SAEs to regulatory authorities, investigators, and IRBs, as applicable. Relative to the first awareness of the eve...	[]
NCT03101293	11.0	STUDY-SPECIFIC COMMITTEES	11.0 STUDY-SPECIFIC COMMITTEES No steering committee, data safety monitoring committee, or clinical endpoint committee will be used in this study.	[]
NCT03101293	12.0	DATA HANDLING AND RECORDKEEPING	12.0 DATA HANDLING AND RECORDKEEPING The full details of procedures for data handling will be documented in the Data Management Plan. AEs, PTEs, medical history, and concurrent medical conditions will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Drugs will be coded using the World Health Or...	[]
NCT03101293	12.1	eCRFs	12.1 eCRFs Completed eCRFs are required for each subject who signs an informed consent. The sponsor or its designee will supply study sites with access to eCRFs. The sponsor will make arrangements to train appropriate site staff in the use of the eCRF. These forms are used to transmit the information collected in the p...	[]
NCT03101293	12.2	Record Retention	12.2 Record Retention The investigator agrees to keep the records stipulated in Section [12.1](#page-58-1) and those documents that include (but are not limited to) the study-specific documents, the identification log of all participating subjects, medical records, temporary media such as thermal sensitive paper, sourc...	[]
NCT03101293	13.0	STATISTICAL METHODS	13.0 STATISTICAL METHODS	[]
NCT03101293	13.1	Statistical and Analytical Plans	13.1 Statistical and Analytical Plans A statistical analysis plan (SAP) will be prepared and finalized prior to database lock. This document will provide further details regarding the definition of analysis variables and analysis methodology to address all study objectives. A targeted data review will be conducted prio...	[]
NCT03101293	13.1.1	Analysis Sets	13.1.1 Analysis Sets Safety Analysis Set The safety analysis set will consist of all enrolled subjects who received at least 1 dose of study drug. Subjects in this analysis set will be used for demographic, other baseline characteristic, and safety summaries. PK Analysis Set The PK analysis set will consist of subjects...	[]
NCT03101293	13.1.2	Analysis of Demographics and Other Baseline Characteristics	13.1.2 Analysis of Demographics and Other Baseline Characteristics Demographic and other baseline characteristic data will be summarized for all enrolled subjects by treatment sequence, and overall. Summary statistics (eg, number of subjects, mean, median, SD, and range) will be generated for continuous variables (eg, ...	[]
NCT03101293	13.1.3	PK Analysis	13.1.3 PK Analysis	[]
NCT03101293	13.1.3.1	TAK-831 Concentrations in Plasma	13.1.3.1 TAK-831 Concentrations in Plasma For each regimen, TAK-831 plasma concentrations will be summarized using descriptive statistics (mean, median, SD, %CV, minimum, and maximum) for each scheduled sampling time. Individual subject plasma concentration data will be listed.	[]
NCT03101293	13.1.3.2	Plasma PK Parameters	13.1.3.2 Plasma PK Parameters For each regimen, TAK-831 plasma PK parameter estimates will be summarized using descriptive statistics (N, mean, median, SD, %CV, minimum, and maximum). In addition, geometric means will be calculated for Cmax and AUCs. Individual subject plasma PK parameter data will be listed. Analysis ...	[]
NCT03101293	13.1.4	PD Analysis	13.1.4 PD Analysis ![](page61Picture10.jpeg)	[]
NCT03101293	13.1.4.2	Plasma PD Parameters	13.1.4.2 Plasma PD Parameters ![](page61Picture12.jpeg) Additional statistical or PK/PD analyses will be performed as appropriate.	[]
NCT03101293	13.1.5	Safety Analysis	13.1.5 Safety Analysis No statistical testing will be performed or inferential statistics will be generated.	[]
NCT03101293	13.1.5.1	AEs	13.1.5.1 AEs All AEs will be coded by system organ class (SOC) and preferred term (PT) using MedDRA. TEAEs with onset occurring within 30 days (onset date – last date of dose +1≤30) after the last dose of study drug will be included in the summary tables. TEAEs will be summarized by SOC and PT with descriptive statisti...	[]
NCT03101293	13.1.5.2	Clinical Laboratory Evaluations	13.1.5.2 Clinical Laboratory Evaluations Individual clinical laboratory test data (hematology, chemistry, and urinalysis) will be listed for all subjects. Baseline, postdose, and changes from Baseline to postdose data will be summarized by regimen for each scheduled time point using descriptive statistics. The Baseline...	[]
NCT03101293	13.1.5.3	Vital Signs	13.1.5.3 Vital Signs Individual vital sign data (oral temperature, respiration rate, blood pressure, and heart rate) will be listed for all subjects. Baseline, postdose, and changes from Baseline to postdose data will be summarized by regimen for each scheduled time point using descriptive statistics. The Baseline for ...	[]
NCT03101293	13.1.5.4	ECGs	13.1.5.4 ECGs Individual quantitative 12-lead ECG data will be listed for all subjects. Baseline, postdose, and changes from Baseline in quantitative ECG data will be summarized by regimen for each scheduled time point using descriptive statistics. The baseline is defined as the last observation prior to the dose of st...	[]
NCT03101293	13.1.5.5	Other Variables	13.1.5.5 Other Variables Individual physical examination findings will be listed for all subjects.	[]
NCT03101293	13.2	Interim Analysis and Criteria for Early Termination	13.2 Interim Analysis and Criteria for Early Termination No interim analysis is planned. CONFIDENTIAL	[ "CONFIDENTIAL" ]
NCT03101293	13.3	Determination of Sample Size	13.3 Determination of Sample Size With a sample size of 16 subjects (8 subjects per treatment sequence), allowing for a maximum of 2 dropouts, a 2-sided 90% CI for the difference in the paired means of the lnCmax will extend 0.23 from the observed mean. Assuming a point estimate of the food effect of 2 (observed ratio ...	[]
NCT03101293	14.0	QUALITY CONTROL AND QUALITY ASSURANCE	14.0 QUALITY CONTROL AND QUALITY ASSURANCE	[]
NCT03101293	14.1	Study-Site Monitoring Visits	14.1 Study-Site Monitoring Visits Monitoring visits to the study site will be made periodically during the study to ensure that all aspects of the protocol are followed. Source documents will be reviewed for verification of data recorded on the eCRFs. Source documents are defined as original documents, data, and record...	[]
NCT03101293	14.2	Protocol Deviations	14.2 Protocol Deviations The investigator should not deviate from the protocol, except where necessary to eliminate an immediate hazard to study subjects. Should other unexpected circumstances arise that will require deviation from protocol-specified procedures, the investigator should consult with the sponsor or desig...	[]
NCT03101293	14.3	Quality Assurance Audits and Regulatory Agency Inspections	14.3 Quality Assurance Audits and Regulatory Agency Inspections The study site also may be subject to quality assurance audits by the sponsor or designees. In this circumstance, the sponsor-designated auditor will contact the site in advance to arrange an auditing visit. The auditor may ask to visit the facilities wher...	[]
NCT03101293	15.0	ETHICAL ASPECTS OF THE STUDY	15.0 ETHICAL ASPECTS OF THE STUDY This study will be conducted with the highest respect for the individual participants (ie, subjects) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the ICH Harmonised Tripartite Guideline for GCP. Each investigator will cond...	[]
NCT03101293	15.1	IRB Approval	15.1 IRB Approval IRBs must be constituted according to the applicable requirements of each participating region. The sponsor or designee will require documentation noting all names and titles of members who make up the respective IRB. If any member of the IRB has direct participation in this study, written notificatio...	[]
NCT03101293	15.2	Subject Information, Informed Consent, and Subject Authorization	15.2 Subject Information, Informed Consent, and Subject Authorization Written consent documents will embody the elements of informed consent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations. The informed consent form, subject a...	[]
NCT03101293	15.3	Subject Confidentiality	15.3 Subject Confidentiality The sponsor and designees affirm and uphold the principle of the subject's right to protection against invasion of privacy. Throughout this study, a subject's source data will only be linked to the sponsor's clinical study database or documentation via a subject identification number. As pe...	[]
NCT03101293	15.4	Publication, Disclosure, and Clinical Trial Registration Policy	15.4 Publication, Disclosure, and Clinical Trial Registration Policy	[]
NCT03101293	15.4.1	Publication and Disclosure	15.4.1 Publication and Disclosure The investigator is obliged to provide the sponsor with complete test results and all data derived by the investigator from the study. During and after the study, only the sponsor may make study information available to other study investigators or to regulatory agencies, except as req...	[]
NCT03101293	15.4.2	Clinical Trial Registration	15.4.2 Clinical Trial Registration In order to ensure that information on clinical trials reaches the public in a timely manner and to comply with applicable laws, regulations, and guidance, Takeda will, at a minimum register all interventional clinical trials it sponsors anywhere in the world on ClinicalTrials.gov and...	[]
NCT03101293	15.4.3	Clinical Trial Results Disclosure	15.4.3 Clinical Trial Results Disclosure Takeda will post the results of clinical trials on ClinicalTrials.gov or other publicly accessible websites, as required by Takeda Policy/Standard, applicable laws, and/or regulations.	[]
NCT03101293	15.5	Insurance and Compensation for Injury	15.5 Insurance and Compensation for Injury Each subject in the study must be insured in accordance with the regulations applicable to the site where the subject is participating. If a local underwriter is required, then the sponsor or sponsor's designee will obtain clinical study insurance against the risk of injury to...	[]
NCT03101293	16.0	REFERENCES	16.0 REFERENCES - 1. Fredericks CM. Disorders of the cerebellum and its connections. In: Fredericks C, Saladin LK, editors. Pathophysiology of the Motor Systems: Principles and Clinical Presentations. Philadelphia, PA: F. A. Davis; 1996. - 2. Wilson CL, Fahey MC, Corben LA, Collins VR, Churchyard AJ, Lamont PJ, et al. ...	[ "Appendix A Schedule of Study Procedures", "Footnotes for Appendix A:", "Appendix B Responsibilities of the Investigator", "Appendix C Elements of the Subject Informed Consent", "Appendix D Investigator Consent to Use of Personal Information", "Appendix E Detailed Description of Amendments to Text", "In...
NCT03104699	1	INTRODUCTION AND RATIONALE	1. INTRODUCTION AND RATIONALE In the past 2 decades, researchers have demonstrated the importance of the immune system in controlling cancer. Advances in our understanding of immuno-oncology have highlighted the dynamic interplay between host and tumor, and have shown that a tumor's ability to evade the immune system c...	[]
NCT03104699	1.1	PD-1 Checkpoint Blockade	1.1. PD-1 Checkpoint Blockade	[]
NCT03104699	1.1.1	PD-1 Pathway Blockade	1.1.1. PD-1 Pathway Blockade The importance of immune surveillance in controlling outgrowth of neoplastic transformation is well described and consistent with a correlation between prevalence of tumor-infiltrating lymphocytes in cancer tissues and favorable prognosis in various malignancies [\(Disis 2010\)](#page-106-2...	[]
NCT03104699	1.1.2	AGEN2034	1.1.2. AGEN2034 AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block PD-1 from interacting with its ligand PD-L1 and PD-L2 in a manner comparable to nivolumab.	[]
NCT03104699	1.1.2.1	Summary of Preclinical Data	1.1.2.1. Summary of Preclinical Data The utility of PD-1 as a therapeutic antibody target in human cancer has been well characterized. A human immunoglobulin G4 antibody with immunoglobulin kappa light chains (IgG4κ) monoclonal antibody directed against PD-1 (nivolumab, Opdivo®) has been evaluated in thousands of patie...	[]
NCT03104699	1.1.2.2	Summary of Clinical Data	1.1.2.2. Summary of Clinical Data There are no existing safety data for AGEN2034, as this study will support its first human administration. The best indication of the safety profile of AGEN2034 is expected to be the safety profile of nivolumab (Opdivo®), as specified in its prescribing information (Opdivo® 2017). Per ...	[]
NCT03104699	1.1.3	Safety of Nivolumab	1.1.3. Safety of Nivolumab The following safety information is based on data from 7 clinical trials in which 2,166 subjects received nivolumab as a single agent for treatment of unresectable or metastatic melanoma, metastatic NSCLC, advanced renal cell carcinoma (RCC), and classical Hodgkin's lymphoma (cHL). Across all...	[]
NCT03104699	1.1.3.1	Common Adverse Reactions of Nivolumab	1.1.3.1. Common Adverse Reactions of Nivolumab Adverse reactions observed in more than 20% of subjects treated with nivolumab in clinical trials included (Opdivo® 2015): - In melanoma: Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, and nausea. - In metastatic NSCLC: Fatigue, musculoskeletal pain, decreased ap...	[]
NCT03104699	1.1.3.2	Notable Immune-Mediated Adverse Reactions of Nivolumab	1.1.3.2. Notable Immune-Mediated Adverse Reactions of Nivolumab Immune-mediated conditions are defined as adverse reactions requiring the use of corticosteroids, with no clear alternate etiology. The most common immune-mediated reactions associated with nivolumab include pneumonitis (including interstitial lung disease...	[]
NCT03104699	1.2	Rationale for Dose Selection	1.2. Rationale for Dose Selection	[]
NCT03104699	1.2.1	Starting Dose in Phase 1	1.2.1. Starting Dose in Phase 1 The NOAEL of AGEN2034 from the 4-week cynomolgus monkey toxicity study was 40 mg/kg (see [Section](#page-21-1) 1.1.2.1). This dose and serum AGEN2034 concentrations were used in the calculations below for the safe starting dose. For the clinical trial, the starting dose of 1 mg/kg was se...	[]
NCT03104699	1.2.2	Dose in Phase 2	1.2.2. Dose in Phase 2 The choice of the Phase 2 dose was based on clinical data from the Phase 1 portion of this trial, evaluating AGEN2034 as monotherapy. Supportive clinical responses are also available from publications of similar-mechanism competitor nivolumab (anti PD-1; Opdivo®) as monotherapy since AGEN2034 has...	[]
NCT03104699	1.3	Rationale for Expansion Cohort	1.3. Rationale for Expansion Cohort Subjects with unresectable or metastatic cervical cancer with disease progression after a platinum-based treatment regimen will be enrolled in an expansion cohort. This population has a high unmet need for effective therapy, and there is a strong rationale for the use of a PD-1 thera...	[]
NCT03104699	1.4	Rationale for Biomarker Assessment	1.4. Rationale for Biomarker Assessment	[]
NCT03104699	1.4.1	Biomarkers in Phase 1	1.4.1. Biomarkers in Phase 1 When the study started, due to limited understanding of the biological activities induced by AGEN2034 in cancer subjects, there was no certainty that the doses examined will be associated with relevant antitumor immune activities. As a consequence, the study will serve to: evaluate receptor...	[]
NCT03104699	1.4.2	Biomarkers in Phase 2	1.4.2. Biomarkers in Phase 2 Phase 2 of the study will continue to investigate the mechanism of action of the drug by monitoring immune cell subset activation status; will monitor as a non-invasive reflection of the tumor burden; will evaluate potential predictive/prognostic biomarker candidates related to the drug and...	[]
NCT03104699	1.4.3	Assessment of PD-L1 Expression in Tumors	1.4.3. Assessment of PD-L1 Expression in Tumors PD-L1 expression has been associated with response to PD-1. In treatment naive NSCLC, a PD-L1 expression level of ≥ 50% tumor proportion score (TPS) as a companion diagnostic for treatment with pembrolizumab was evaluated and is now approved. There is limited data availab...	[]
NCT03104699	2	OBJECTIVES, ENDPOINTS, AND BENEFIT/RISK	2. OBJECTIVES, ENDPOINTS, AND BENEFIT/RISK	[]
NCT03104699	2.1	Objectives and Endpoints	2.1. Objectives and Endpoints The objectives and associated endpoints for Phase 1 and Phase 2 are shown in Section 2.1.1 and [Section](#page-30-0) 2.1.2, respectively.	[]
NCT03104699	2.1.1	Phase 1	2.1.1. Phase 1 \| \| Objective \| Endpoint \| \|-------------\|-----------------------------------------------------------------------------------------------------------------------------------\|-----------------------------------------------------------------------------------------------------------------------------------...	[]
NCT03104699	2.1.2	Phase 2	2.1.2. Phase 2 \| 2.1.2. \| Phase 2Objective \| Endpoint \| \|-----------\|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------\|-----------------------------------------------------------...	[]
NCT03104699	2.2	Overall Risk/Benefit Assessment	2.2. Overall Risk/Benefit Assessment The risk-benefit relationship has been carefully considered in the planning of this trial. Based on preclinical and clinical data available to date, the conduct of the trial is considered safe and reasonable using the dose and schedule of AGEN2034 as specified for Phase 1, Cohort 1 ...	[]
NCT03104699	3	INVESTIGATIONAL PLAN	3. INVESTIGATIONAL PLAN This is a 2-part trial: a Phase 1, open-label, dose-escalation trial in subjects with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed afte...	[]
NCT03104699	3.1	Phase 1 (Part A): Dose Escalation	3.1. Phase 1 (Part A): Dose Escalation Phase 1 (Part A) of the study will consist of a standard 3+3 dose escalation with the following escalating dose levels and schedules: - Part A1: 1, 3, and 10 mg/kg administered every 2 weeks - Part A2: 6 and 10 mg/kg administered every 3 weeks In Part A1, the first subject of each...	[]
NCT03104699	3.1.1	Dose-Limiting Toxicity	3.1.1. Dose-Limiting Toxicity In this trial, a DLT is defined as any treatment-related toxicity that is NCI CTCAE Grade ≥ 3, confirmed by the SMC to be relevant for the study drug treatment, and that occurs during the first 3 weeks of AGEN2034 treatment in the dose escalation portion of the trial (DLT evaluation period...	[]
NCT03104699	3.1.2	Stopping Rules for Toxicity	3.1.2. Stopping Rules for Toxicity The SMC will meet to review any cohort under evaluation as well as the safety of all cohorts. Should > 33% subjects on any dose level experience toxicities that meet DLT criteria but occur after the DLT observation period or in subjects not included in the DLT analysis set, enrollment...	[]
NCT03104699	3.1.3	Backfill Expansion Enrollment for Each Dose Level Cohort in the Phase 1	3.1.3. Backfill Expansion Enrollment for Each Dose Level Cohort in the Phase 1 Concurrent with the 3+3 dose escalation schema, additional subjects will be backfilled to ensure that each combined dose level cohort enrolls at least 10 subjects: - Part A1: - − Once the safety of the 1 mg/kg dose is established, enrollment...	[ "• Part A2:" ]
NCT03104699	3.2	Phase 2: Dose Expansion Phase	3.2. Phase 2: Dose Expansion Phase There is no approved standard of care for second line treatment of advanced or metastatic cervical cancer. As such, these subjects would be eligible for the Phase 1 portion of the study; therefore, the SMC may decide to open enrollment to the expansion cohorts of this trial at a dose ...	[]
NCT03104699	3.3	Planned Number of Subjects	3.3. Planned Number of Subjects	[]
NCT03104699	3.3.1	Enrollment Targets	3.3.1. Enrollment Targets The planned number of subjects for this trial is: - Phase 1 (Parts A1 and A2): approximately 50 subjects. - Phase 2: approximately 150 subjects with recurrent, unresectable and/or metastatic cervical cancer. The final sample size may vary depending on the total number of dose levels tested, an...	[]
NCT03104699	3.3.2	Subject Replacement Strategy	3.3.2. Subject Replacement Strategy In Phase 1, subjects who do not complete the DLT observation period defined in [Section](#page-32-1) 3.1 for reasons other than a DLT may be replaced. In Phase 2, no subject will be replaced.	[]
NCT03104699	3.4	Planned Trial Duration	3.4. Planned Trial Duration The maximum trial duration for a subject is estimated to be up to approximately 49 months. This includes a screening period, a planned treatment period of up to approximately 24 months, and a follow-up period of up to 24 months after the last dose of study drug. The overall trial duration is...	[]
NCT03104699	3.5	Definition of End of Trial	3.5. Definition of End of Trial If the trial is not terminated for a reason provided in [Section](#page-45-0) 4.4.3, the end of the trial is defined as 24 months after the last subject has received the last planned dose of study drug.	[]
NCT03104699	3.6	Medical Care of Subjects After End of Trial	3.6. Medical Care of Subjects After End of Trial At the end of the protocol-specified periods of active study therapy, the Sponsor will not continue to supply study drug to subjects/investigators unless the Sponsor chooses to extend the study. The investigator should ensure that the subject receives appropriate standar...	[]
NCT03104699	4	SELECTION OF TRIAL POPULATION	4. SELECTION OF TRIAL POPULATION	[]
NCT03104699	4.1	Target Population	4.1. Target Population Phase 1 (Parts A1 and A2): Male and female subjects over the age of 18 years with metastatic or locally advanced solid tumors for which no standard therapy is available or standard therapy has failed. Phase 2: Female subjects over the age of 18 years with recurrent and/or metastatic cervical can...	[ "Phase 2:" ]
NCT03104699	4.2	Inclusion Criteria	4.2. Inclusion Criteria For inclusion in the trial, all of the following inclusion criteria must be fulfilled as no waivers will be permitted: - 1. Voluntarily agree to participate by giving written informed consent. Participation in pharmacogenomics testing is optional. - 2. Be ≥ 18 years of age. - 3. Diagnosis and pr...	[ "b. Phase 2:" ]
NCT03104699	4.3	Exclusion Criteria	4.3. Exclusion Criteria The subject must be excluded from participating in the trial if the subject: - 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks before the first dose of t...	[]
NCT03104699	4.4	Criteria for Subject Withdrawal	4.4. Criteria for Subject Withdrawal	[]
NCT03104699	4.4.1	Withdrawal from Treatment	4.4.1. Withdrawal from Treatment The subject must be withdrawn in the event of any of the following: - Occurrence of an event that would have been considered an exclusion criterion prior to enrollment, that is clinically relevant and affects the subject's safety, and if discontinuation is considered necessary by the in...	[]
NCT03104699	4.4.2	Withdrawal from the Trial	4.4.2. Withdrawal from the Trial Subjects are free to discontinue the trial at any time without giving their reasons. A subject must be withdrawn in the event of any of the following: - Withdrawal of the subject's consent. - Participation in any other therapeutic trial during the treatment duration of this trial. If a ...	[]

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