Clinical Trials in China / NCT07208136
Recruiting
Phase 1
A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors
NCT07208136 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumors
Investigational drug(s) / intervention(s)
JMKX005425
JMKX005425: JMKX005425 administered orally.
Study 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 subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.
Eligibility
Inclusion Criteria:
1. Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documented advanced solid tumor.
2. Has at least one measurable lesion per RECIST v1.1.
3. Has a life expectancy of ≥ 12 weeks.
4. Adequate organ function.
Exclusion Criteria:
1. Toxicities from prior anti-tumor therapy has not recovered to Grade 1 or below per CTCAE v5.0.
2. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
3. Has the dysphagia, or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug.
4. Has the severe chronic or active infection
5. Has a history of severe cardiovascular disease.
6. Subject is pregnant or breastfeeding.
Primary outcome measure(s)
- Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs) — up to 2 years
To assess the safety and tolerability of JMKX005425.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07208136 on ClinicalTrials.gov ↗ ← All trials in China