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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07208136

Enrollment

102

Registered

2025-10-06

Start date

2025-10-22

Completion date

2028-12-31

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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 subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.

Interventions

DRUGJMKX005425

JMKX005425 administered orally.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)	up to 2 years	To assess the safety and tolerability of JMKX005425.

Secondary

Measure	Time frame	Description
maximum plasma concentration (Cmax)	Up to 2 months	Maximum observed concentration.
maximum plasma concentration (Tmax)	Up to 2 months	Time to reach maximum observed plasma concentration.
Objective Response Rate (ORR)	Up to 2 years	ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease Control Rate (DCR)	Up to 2 years	DCR is the percentage of patients with a best overall response of CR or PR or Stable Disease (SD) per RECIST v1.1.

Countries

China

Contacts

Primary ContactLu Chen

chenlu5@jeyoupharma.com+86 17717684840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026