JMKX005425 for people with MSI‑H or dMMR advanced solid tumors

An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX005425 Tablets in Subjects With Microsatellite Instability-High or Mismatch Repair Deficient Advanced Solid Tumors

This trial will try JMKX005425 in people with MSI‑H or dMMR advanced solid tumors to see if it is safe, well tolerated, how the body processes it, and whether it shows early signs of benefit.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07208136 on ClinicalTrials.gov

What this trial studies

This first‑in‑human, Phase 1, open‑label, multi‑center study uses a dose‑escalation stage to define safety, tolerability, and a recommended dose, followed by dose‑expansion cohorts in patients with MSI‑H and/or dMMR advanced solid tumors. Patients must have at least one measurable lesion per RECIST v1.1 and adequate organ function, and will be followed for adverse events graded by CTCAE v5.0 and for tumor response by RECIST v1.1. Pharmacokinetic sampling will characterize how the drug is absorbed and cleared, and preliminary anti‑tumor activity will be recorded during the expansion phase. The trial is sponsored by Jemincare with sites including Beijing Cancer Hospital.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically or cytologically documented MSI‑H and/or dMMR advanced solid tumors, at least one measurable lesion, a life expectancy of 12 weeks or more, and adequate organ function who have recovered from prior treatment toxicities.

Not a fit: Patients without MSI‑H/dMMR tumors, those with unresolved Grade ≥2 toxicities from prior therapy, severe active infections or cardiovascular disease, significant gastrointestinal conditions affecting drug absorption, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, JMKX005425 could offer a new treatment option for patients with MSI‑H/dMMR advanced solid tumors, potentially producing clinical responses with an acceptable safety profile.

How similar studies have performed: Other approaches, notably PD‑1 inhibitors, have shown strong clinical activity in MSI‑H/dMMR tumors, but JMKX005425 is a first‑in‑human agent and its clinical benefit remains unproven.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Lin Shen — Peking University Cancer Hospital & Institute
• Study coordinator: Lu Chen

Conditions Advanced Solid Tumors