A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJemincare
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- JMKX005425
Treatment groups
102 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov