A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation

ConditionNSCLC (Advanced Non-small Cell Lung Cancer)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorJemincare

About this trial

This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.

Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.

Measurable disease according to RECIST 1.1.

An Eastern Cooperative Group (ECOG) performance status of 0 or 1.

Disqualifiers

Subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.

Prior chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).

History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.

Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.

Trial design

Design model

Sequential

Treatments tested in this trial

JMKX001899
Drug
JMKX001899 tablet administered orally daily.
IN10018
Drug
IN10018 tablet administered orally daily.
Chemotherapy: Pemetrexed
Drug
IV infusion once every 3 weeks
Carboplatin
Drug
IV infusion once every 3 weeks, 4 Cycles

Treatment groups

72 Participants

are divided into 3 treatment groups

Group A: Cohort A: JMKX001899+IN10018Experimental treatment 2 interventions

Group B: Cohort B: JMKX001899+chemotherapyExperimental treatment 3 interventions

Group C: Cohort C: JMKX001899+IN10018+chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Recommended Phase II dose (RP2D)

Time frame

approximately 1 year

adverse events

Time frame

Through study completion, approximately 2.5 years

Sponsors and contacts

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

Jemincare

Lead sponsor

Source ClinicalTrials.gov

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