A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JMKX005425.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Drug JMKX005425
JMKX005425 administered orally.
Primary outcome measures
- Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs) [Time frame: up to 2 years]
Secondary outcome measures (4)
- maximum plasma concentration (Cmax) [Time frame: Up to 2 months]
- maximum plasma concentration (Tmax) [Time frame: Up to 2 months]
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
- Disease Control Rate (DCR) [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT07208136 · JMKX005425-X101