Actively Recruiting
A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors
Led by JiaRay Group · Updated on 2025-09-09
94
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.
CONDITIONS
Official Title
A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed locally advanced or metastatic solid tumor progressed on or intolerant to standard therapy or no standard therapy available or refused
- Measurable disease per RECIST v1.1
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function as defined by blood counts, liver enzymes, creatinine clearance, and coagulation tests
- Patients with treated, stable central nervous system metastases without progression for at least 4 weeks
- Resolution of prior therapy toxic effects to Grade 1 or less (except alopecia and Grade 2 peripheral neuropathy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willingness to use effective birth control during and after treatment if of reproductive potential
- Negative pregnancy test for women of childbearing potential within screening and before treatment
- Able and willing to provide informed consent and comply with study requirements
- For expansion cohorts: documented locally advanced or metastatic gastric, esophagogastric junction cancer, or colorectal cancer with progression after standard therapy or intolerance or refusal of therapy
You will not qualify if you...
- Any condition that poses unacceptable risk or would prevent full participation or compliance
- Received systemic anticancer treatments or investigational agents within 2 weeks or 5 half-lives before starting study drug
- Major surgery within 3 weeks before starting study drug
- Radiation therapy within 4 weeks before starting study drug (with exceptions for recent palliative radiation)
- Severe or unstable cardiac conditions including heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmias, recent myocardial infarction, long QT syndrome, or other unstable cardiac illnesses
- Severe or unstable medical conditions including uncontrolled diabetes or unstable psychiatric conditions
- History of another active cancer within the past 2 years except certain localized, low-risk cancers
- Active infection requiring systemic therapy
- Known HIV, active hepatitis B or C infection (with exceptions for treated and controlled cases)
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Harbin Medical University Cancer Hospital
Harbin, Heiljiang Province, China, 150040
Actively Recruiting
2
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042
Actively Recruiting
Research Team
S
Sam Chu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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