Actively Recruiting
A First-in-Human, Open-Label, Dose Escalation and Expansion Study of JR8603 in Patients With Advanced Solid Tumors
Led by JiaRay Group · Updated on 2025-09-09
94
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying JR8603, an investigational drug, to see if it is safe and effective for patients with advanced solid tumors that have not improved after standard treatments. This early phase, first-in-human, open-label trial focuses on patients with locally advanced or metastatic solid tumors who have progressed despite or cannot tolerate standard therapies. The study aims to find the right dose and observe preliminary effects of JR8603. The study has two parts: Dose Escalation and Dose Expansion. JR8603 is given as a short intravenous infusion on Days 1, 8, and 15 of repeated 28-day cycles. During Dose Escalation, doses start low and may increase to find the maximum tolerated dose using a stepwise approach with small groups of patients. Dose Expansion then evaluates the drug further at selected doses in specific groups of patients with gastric, esophagogastric junction, or colorectal cancers. Participants will have scans (CT or MRI) to measure tumor response every 8 weeks for the first year, then every 12 weeks afterward. Researchers will collect blood samples to study how the drug is processed in the body. Safety is closely monitored using standard criteria, and various outcomes such as adverse events, response rates, and survival will be tracked up to about one year after the last dose. Total participation time varies based on individual treatment and response.
CONDITIONS
Brief 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...
- Age 18 years or older
- Histologically confirmed, locally advanced or metastatic solid tumor progressed after or intolerant to all standard therapy, or no standard therapy available, or therapy refused by patient
- Measurable disease per RECIST v1.1
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function as defined by specified blood counts and liver, kidney, and coagulation tests
- Stable treated central nervous system metastases with no progression for at least 4 weeks
- Resolution of significant toxic effects of prior therapy to Grade 1 or less (except alopecia and Grade 2 peripheral neuropathy)
- ECOG performance status of 0 or 1
- Willingness to use effective birth control methods during treatment and for specified periods afterward
- Negative pregnancy test for women of childbearing potential before dosing
- Ability to provide informed consent and comply with study requirements
- Specific criteria for Expansion Cohort 1: advanced gastric or esophagogastric junction cancer progressed after standard therapy or intolerant/refused therapy
- Specific criteria for Expansion Cohort 2: advanced colorectal cancer progressed after standard therapy or intolerant/refused therapy
You will not qualify if you...
- Any condition posing unacceptable risk or interfering with study participation
- Receipt of systemic anticancer therapy or investigational agent within 2 weeks prior to study drug
- Major surgery within 3 weeks prior to study drug
- Radiation therapy within 4 weeks prior to study drug (with some exceptions for palliative radiation)
- Severe or unstable cardiac conditions including heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, recent heart attack, or abnormal QTc interval
- Severe or unstable medical conditions such as uncontrolled diabetes or psychiatric illness
- History of another active cancer within 2 years except certain localized, low-risk cancers
- Active infection requiring systemic therapy
- Known HIV, active hepatitis B or C infection (with some exceptions for treated or controlled cases)
- Pregnant or breastfeeding women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for CT or MRI within 28 days before first dose
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive JR8603 as a short IV infusion on Days 1, 8, and 15 of continuous 28-day cycles. Dose escalation and expansion cohorts are used to determine safety, tolerability, and preliminary efficacy.
3 infusion visits per 28-day cycle (Days 1, 8, and 15) with imaging assessments every 8 weeks for the first year and every 12 weeks thereafter
Duration - Up to approximately 1 year after last dose
Participants are monitored for adverse events, dose-limiting toxicities, and treatment response for up to approximately 1 year after the last dose.
Visits for safety and efficacy assessments up to 28 days after last dose and periodic follow-up visits as needed
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
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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