Status:
RECRUITING
A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors
Lead Sponsor:
Jemincare
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in ...
Eligibility Criteria
Inclusion
- Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documented advanced solid tumor.
- Has at least one measurable lesion per RECIST v1.1.
- Has a life expectancy of ≥ 12 weeks.
- Adequate organ function.
Exclusion
- Toxicities from prior anti-tumor therapy has not recovered to Grade 1 or below per CTCAE v5.0.
- History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- Has the dysphagia, or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug.
- Has the severe chronic or active infection
- Has a history of severe cardiovascular disease.
- Subject is pregnant or breastfeeding.
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT07208136
Start Date
October 22 2025
End Date
December 1 2028
Last Update
December 1 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, China, 100142