Clinical trial · Interventional
A Study of JMKX005425 in Patients With MSI-H/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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMKX005425 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JMKX005425
- description
- Subjects will take a pre-specified dose of JMKX005425.
- interventionNames
- Drug: JMKX005425
Primary outcomes (1)
- measure
- Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)
- timeFrame
- up to 2 years
- description
- To assess the safety and tolerability of JMKX005425.
Secondary outcomes (4)
- measure
- maximum plasma concentration (Cmax)
- timeFrame
- Up to 2 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available