Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • JMKX005425

    Drug

    JMKX005425 administered orally.

Treatment groups

102 Participants
are divided into 1 treatment group
Group A: JMKX005425Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

To assess the safety and tolerability of JMKX005425.

Time frame
up to 2 years

Secondary outcomes

1

maximum plasma concentration (Cmax)

Maximum observed concentration.

Time frame
Up to 2 months
2

maximum plasma concentration (Tmax)

Time to reach maximum observed plasma concentration.

Time frame
Up to 2 months
3

Objective Response Rate (ORR)

ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Time frame
Up to 2 years
4

Disease Control Rate (DCR)

DCR is the percentage of patients with a best overall response of CR or PR or Stable Disease (SD) per RECIST v1.1.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov
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