RecruitingPhase 1

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

China102 participantsStarted 2025-10-22

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

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

Timeframe: up to 2 years

Trial details

NCT IDNCT07208136

SponsorJemincare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Lu Chen

+86 17717684840 chenlu5@jeyoupharma.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials