JMKX005425 for people with MSI‑H or dMMR advanced solid tumors
Official title: 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
Run by Jemincare · NCT07208136 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Jemincare Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07208136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Beijing Cancer Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Lin Shen — Peking University Cancer Hospital & Institute
- Study coordinator: Lu Chen
- Email: chenlu5@jeyoupharma.com
- Phone: +86 17717684840
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
AK157D1 injection for advanced solid tumors
A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.
-
ABBV-253 in adults with advanced solid tumors
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
-
MK-2010 alone or with other treatments for advanced solid tumors
This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.
-
Whole-Body Infrared Heating for Advanced Solid Tumors
This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.
-
MK-2010 with Sac-TMT in advanced solid tumors
This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.