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NCT Number: NCT07208136

A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documented advanced solid tumor.
  • Has at least one measurable lesion per RECIST v1.1.
  • Has a life expectancy of ≥ 12 weeks.
  • Adequate organ function.

Exclusion criteria

  • Toxicities from prior anti-tumor therapy has not recovered to Grade 1 or below per CTCAE v5.0.
  • History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
  • Has the dysphagia, or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug.
  • Has the severe chronic or active infection
  • Has a history of severe cardiovascular disease.
  • Subject is pregnant or breastfeeding.

Treatment and study plan

JMKX005425

Drug

JMKX005425 administered orally.

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)

    Time frame: up to 2 years

    To assess the safety and tolerability of JMKX005425.

Secondary outcomes

  1. maximum plasma concentration (Cmax)

    Time frame: Up to 2 months

    Maximum observed concentration.

  2. maximum plasma concentration (Tmax)

    Time frame: Up to 2 months

    Time to reach maximum observed plasma concentration.

  3. Objective Response Rate (ORR)

    Time frame: 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.

  4. Disease Control Rate (DCR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Chen

CONTACT

[email protected]

+86 17717684840

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 6, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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