input stringlengths 317 13.1k | output dict |
|---|---|
This expanded access protocol was designed to provide TJ004309 in combination with
atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to
continue with treatment.
;NA;
Inclusion Criteria:
1. Participation in the Tracon sponsored 4309ST101 study and thought to have potential to
... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is
typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can
cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are
available, but MM can come back (relapsed) o... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib
80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and
stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary
endpoint is the disease-free survival r... | {
"inclusion_biomarker": [
[
"EGFR mutation"
],
[
"EGFR exon 19 deletion"
],
[
"EGFR L858R"
],
[
"EGFR S768I"
],
[
"EGFR G719X"
],
[
"EGFR L861Q"
],
[
"EGFR T790M"
]
],
"exclusion_biomarker": [
[
"EGFR exon... |
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects
with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk
myelodysplastic syndrome.
;
;
Inclusion Criteria:
1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Conse... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a phase 2 study to evaluate the safety and efficacy of the combination of INCMGA00012
and pelareorep and to see how well they work in treating patients with triple negative breast
cancer that has spread to other parts of the body (metastatic).
INCMGA00012 is a monoclonal antibody that works by attaching to t... | {
"inclusion_biomarker": [
[
"ER negative",
"PR negative",
"HER2 negative"
]
],
"exclusion_biomarker": []
} |
In recent years, the goal of stopping drug therapy, also known as treatment-free remission
(TFR), is emerging as one of the management goals of chronic myeloid leukemia (CML) therapy.
Because there is no available data on Asian patients with CML undergoing tyrosine kinase
inhibitor discontinuation (TKI), the investi... | {
"inclusion_biomarker": [
[
"BCR-ABL e13a2"
],
[
"BCR-ABL e14a2"
]
],
"exclusion_biomarker": []
} |
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+
hematologic malignancies.
;
;
Selected Inclusion Criteria:
1. Histologically confirmed relapsed/refractory hematologic malignancies, including
Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL)
2. ... | {
"inclusion_biomarker": [
[
"CD19 expression"
]
],
"exclusion_biomarker": []
} |
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical
activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in
participants with advanced solid and hematologic cancers.
;NA;
Inclusion Criteria:
- Progressed on standard anticancer therapy or for... | {
"inclusion_biomarker": [
[
"CD20 positive"
]
],
"exclusion_biomarker": []
} |
Product: PSB202 is a novel biological entity consisting of two engineered monoclonal
antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized
anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single
product with the two components of PSB202 enabling a disti... | {
"inclusion_biomarker": [
[
"CD20 expression"
],
[
"CD37 expression"
]
],
"exclusion_biomarker": []
} |
This is a phase 1/2, open label study of D-1553 single agent and combination treatment to
assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and
antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C
mutation.
;NA;
Inclusion criteria
- Subject... | {
"inclusion_biomarker": [
[
"KRas G12C"
]
],
"exclusion_biomarker": []
} |
This is a phase II, prospective, open label, one-center study for evaluation of the addition
of nivolumab to the chemotherapy phase of the neoadjuvant treatment for locally advanced
rectal cancer patients. Subjects must have received no prior treatment for rectal cancer
(chemotherapy, radiotherapy or surgery) and no... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus
Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk,
Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled
Study
;
;
Inclusion Criteria:
- Patholog... | {
"inclusion_biomarker": [
[
"CD20 positive"
]
],
"exclusion_biomarker": [
[
"TP53 mutation"
]
]
} |
RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation
will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be
followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose
Limiting Toxicicities (which will stop the d... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread
of cancer through blood vessels to other organs (metastasis). The formation of new blood
vessels is known as angiogenesis, which is controlled by a growth factor (like a hormone)
called Vascular Endothelial Growth Factor (V... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This study will assess the safety, tolerability, and efficacy of multiple dose levels of
PC14586 in participants with advanced solid tumors containing a TP53 Y220C mutation.
;
;
Inclusion Criteria:
- At least 18 years of age or 12 to 17 years of age after adequate adult safety data
become available
- Advanced so... | {
"inclusion_biomarker": [
[
"TP53 Y220C"
]
],
"exclusion_biomarker": []
} |
The purpose of this first in human (FIH) trial is to characterize the safety and tolerability
of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a
recommended dose for future studies in adult patients with advanced solid tumors in selected
indications.
;
;
Inclusion Criter... | {
"inclusion_biomarker": [],
"exclusion_biomarker": [
[
"KRAS activating mutation"
],
[
"NRAS activating mutation"
],
[
"HRAS activating mutation"
],
[
"BRAF activating mutation"
],
[
"PTPN11 activating mutation"
]
]
} |
The incidence of breast reconstruction failure after conventional photon radiotherapy for
breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for
post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast
cancer can significantly reduce the radiat... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
The purpose of this clinical trial is to evaluate the safety, tolerability and primary
efficacy of JK-1201I in patients with small cell lung cancer (SCLC)
;
;
Inclusion Criteria:
1. Between the age of 18 to 70, male or female;
2. Diagnosed having SCLC via either histology or cytology;
3. Extensive small-cell lun... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The
purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of
DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas
harboring GNAQ/11 mutations.
;
;
In... | {
"inclusion_biomarker": [
[
"GNAQ mutation"
],
[
"GNA11 mutation"
]
],
"exclusion_biomarker": []
} |
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF
V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF
V600E Mutation after first-line treatment
;NA;
Inclusion Criteria:
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 ... | {
"inclusion_biomarker": [
[
"BRAF V600E"
]
],
"exclusion_biomarker": []
} |
For metastatic/advanced NSCLC patients who do not have targetable mutations, either
immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or in
combination with platinum doublet chemotherapy is now a standard of care. However, still
about half of the patients do not benefit due to tre... | {
"inclusion_biomarker": [],
"exclusion_biomarker": [
[
"EGFR mutation"
],
[
"BRAF mutation"
],
[
"ALK mutation"
],
[
"ROS1 mutation"
],
[
"NTRAK mutation"
]
]
} |
The purpose of this study is to determine the efficacy of treating patients with intermediate
risk smoldering multiple myeloma (SMM) with combinational therapy with dexamethasone and
lenalidomide (Rd) and patients with high risk SMM with combinational therapy with Rd and
carfilzomib.
;
;
Inclusion Criteria:
Part... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a phase I, first in human, single arm, open label study that will assess safety,
tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule
by patients with relapsed and refractory multiple myeloma (RRMM).The study will consist of
two parts: dose escalation (Part 1) and dose... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
In the current protocol, we propose a study to evaluate a novel, combined esophageal
sponge-methylation biomarker strategy for the early detection of esophageal squamous cell
carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy
leverages the 'EsophaCap', a swallowable, retrie... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple
myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit
in MM.
;NA;
Inclusion Criteria:
- Adequate bone marrow function
- eGFR ≥ 30 mL/min
- Total bilirubin ≤ 1.5 × upper limit of no... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
A phase I/II study to examine the safety, tolerability, pharmacokinetics and efficacy of
XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion
;NA;
Inclusion Criteria:
1. Male or female subjects aged ≥18 years old;
2. Phase I dose escalation period: Histologically or cytologica... | {
"inclusion_biomarker": [
[
"NTRK fusion"
],
[
"ROS1 fusion"
]
],
"exclusion_biomarker": []
} |
Study STML-901-0119 is a dose-escalation study evaluating multiple doses and schedules of
orally administered SL-901 in patients with Advanced Solid Tumors.
;
;
Inclusion Criteria:
1. 18 years old or older.
2. Population by study stage:
1. Part 1a: Patients with advanced, metastatic, and/or progressive solid tum... | {
"inclusion_biomarker": [
[
"PI3K pathway deregulation"
],
[
"DNA-PK pathway deregulation"
]
],
"exclusion_biomarker": []
} |
The Proseven trial is a prospective interventional study that will evaluate the toxicity and
efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated
treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short
overall treatment time (OTT) of 7 days. ... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
To evaluate the anti cancer effect of VK 2019 in subjects with EBV related nasopharyngeal
carcinoma (NPC) for whom there is no other standard treatment available
;
;
Inclusion Criteria:
- 1 Informed consent obtained prior to any protocol mandated study specific procedures
in accordance with institutional policies... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a first in human, multicenter, open label, Phase 1a/b dose escalation and dose
expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose
escalating fashion in subjects with advanced solid tum... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with
relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy
options. A large body of preclinical data supports a role for IGF-1R inhibition in the
treatment of Ewing sarcoma.
More recently, clini... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
Patients entered into the study will receive ASTX727 orally up to 3 to 8 days prior to
receiving Lutathera treatment to determine whether pre-treatment with ASTX727 results in
re-expression of somatostatin receptor-2 in patients with metastatic neuroendocrine tumours.
The study will use [68Ga]-DOTA-TATE PET to image... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
The purpose of this study is to assess the feasibility, safety and efficacy of GD2/CD70
bi-specific CAR-T cell therapy in patients with GD2 and/or CD70 positive tumor. Another goal
of the study is to learn more about the function of the GD2/CD70 bi-specific CAR-T cells and
their persistency in patients.
;
;
Inclu... | {
"inclusion_biomarker": [
[
"GD2 expression"
],
[
"CD70 expression"
]
],
"exclusion_biomarker": []
} |
This phase I/II trial studies the side effects and best dose of avelumab with M6620 in
treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors
that have spread to other places in the body (metastatic) or cannot be removed by surgery
(unresectable). DDR deficiency refers to a dec... | {
"inclusion_biomarker": [
[
"ARID1A aberration"
],
[
"ATM aberration"
],
[
"ATR aberration"
],
[
"ATRX aberration"
],
[
"BAP1 aberration"
],
[
"BARD1 aberration"
],
[
"BRCA1 aberration"
],
[
"BRCA2 aberration"... |
HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20
insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and
clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC)
patients.
;
;
Inclusion Criteria:
1. Men or women ... | {
"inclusion_biomarker": [
[
"EGFR Exon 20 insertion"
],
[
"HER2 Exon 20 insertion"
]
],
"exclusion_biomarker": []
} |
Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients
(greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma,
advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC)
who have failed all available treatment opti... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant
in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth
factor 2 (HER2)-negative, advanced breast cancer harboring a PIK3CA mutation in Japan, whose
disease has progressed on or after arom... | {
"inclusion_biomarker": [
[
"PIK3CA mutation",
"ER positive",
"HER2 negative"
],
[
"PIK3CA mutation",
"PgR positive",
"HER2 negative"
]
],
"exclusion_biomarker": []
} |
BioEXALK is a prospective study evaluating the biological characteristics of advanced
ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the
national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center
cohort of ALK-rearranged NSCLC patients.
BioExALK study... | {
"inclusion_biomarker": [
[
"ALK rearrangement"
]
],
"exclusion_biomarker": []
} |
The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted
to affect specific genes that are mutated as part of the disease. Mutations in genes can lead
to uncontrolled cell growth and cancer. Patients with a greater than 25% mutation to any of
the following genes; CDKN2C, FGFR3, KR... | {
"inclusion_biomarker": [
[
"CDKN2C mutation"
],
[
"FGFR3 mutation"
],
[
"KRAS mutation"
],
[
"NRAS mutation"
],
[
"BRAF V600E"
],
[
"IDH2 mutation"
],
[
"T(11;14)"
]
],
"exclusion_biomarker": []
} |
This phase II trial studies the effect of larotrectinib in treating patients with NTRK gene
amplification positive solid tumors that have spread to nearby tissues or lymph nodes
(locally advanced) or other places in the body (metastatic). Larotrectinib may stop the
growth of tumor cells by blocking some of the enzym... | {
"inclusion_biomarker": [
[
"NTRK1 amplification"
],
[
"NTRK2 amplification"
],
[
"NTRK3 amplification"
]
],
"exclusion_biomarker": []
} |
In this study, the purpose of this study is to investigate whether prophylactic medical
compression therapy in breast cancer patients receiving docetaxel adjuvant chemotherapy could
reduce the incidence and severity of lymphedema in the upper limbs that received axillary
lymph node resection (sentinel lymph node bio... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
This is a prospective single arm, multi-center, phase II clinical trial to observe the
efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and
Prednisone) in the first-line treatment for patients with marginal zone lymphoma.
;
;
Inclusion Criteria:
1. Age between 18 to 70 years ol... | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
The study comprises two phases: Phase 1a and Phase 1b. The purpose of the study is to observe
the safety， tolerability and efficacy of FS-1502.
;
;
Inclusion Criteria:
1. Age ≥18 years at the time of study registration (men and women eligible);
2. Phase Ia dose-escalation study:
Patients with HER2-expressing adv... | {
"inclusion_biomarker": [
[
"HER2 expression"
],
[
"HER2 positive"
]
],
"exclusion_biomarker": []
} |
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II
clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with
palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The
subjects will receive 20 mg/kg IV Q2W+ ... | {
"inclusion_biomarker": [
[
"HER2 positive"
]
],
"exclusion_biomarker": []
} |
The purpose of this study is to determine the Predictive value of a SNP signature and liquid
biopsy in patients with natural killer T-cell lymphoma.
;NA;
Inclusion Criteria:
- biopsy proved Natural Killer T-cell Lymphoma
- newly diagnosed patients
Exclusion Criteria:
- patients with biopsy samples unavailable | {
"inclusion_biomarker": [],
"exclusion_biomarker": []
} |
Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or
BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have
activity in patients with homologous recombination defects (HRD).
;
;
Inclusion Criteria:
1. Adults ≥19 years old.
2. Pathologicall... | {
"inclusion_biomarker": [
[
"BRCA1 mutation (germline)"
],
[
"BRCA2 mutation (germline)"
],
[
"BRCA1 mutation (somatic)"
],
[
"BRCA2 mutation (somatic)"
],
[
"ATM mutation"
],
[
"BARD1 mutation"
],
[
"BRIP1 mutation"
],... |
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