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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JMKX005425

Subjects will take a pre-specified dose of JMKX005425.

Group Type EXPERIMENTAL

JMKX005425

Intervention Type DRUG

JMKX005425 administered orally.

Interventions

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JMKX005425

JMKX005425 administered orally.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No