NCT07208136

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
31mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

September 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

October 22, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

September 28, 2025

Last Update Submit

November 27, 2025

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

    To assess the safety and tolerability of JMKX005425.

    up to 2 years

Secondary Outcomes (4)

  • maximum plasma concentration (Cmax)

    Up to 2 months

  • maximum plasma concentration (Tmax)

    Up to 2 months

  • Objective Response Rate (ORR)

    Up to 2 years

  • Disease Control Rate (DCR)

    Up to 2 years

Study Arms (1)

JMKX005425

EXPERIMENTAL

Subjects will take a pre-specified dose of JMKX005425.

Drug: JMKX005425

Interventions

JMKX005425DRUG

JMKX005425 administered orally.

JMKX005425

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Study Officials

  • Lin Shen

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Chen

CONTACT

+86 17717684840chenlu5@jeyoupharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2025

First Posted

October 6, 2025

Study Start

October 22, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

December 1, 2025

Record last verified: 2025-09

Locations

CN(1)