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

J

Jemincare

Status and phase

Not yet enrolling
Phase 1

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Treatments

Drug: IN10018
Drug: Carboplatin
Drug: Chemotherapy: Pemetrexed
Drug: JMKX001899

Study type

Interventional

Funder types

Industry

Identifiers

NCT06946927
JMKX1899-C101

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
  2. Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
  3. Measurable disease according to RECIST 1.1.
  4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
  5. Adequate organ function.

Exclusion criteria

  1. 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.
  2. 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).
  3. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
  4. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

72 participants in 3 patient groups

Cohort A: JMKX001899+IN10018
Experimental group
Treatment:
Drug: JMKX001899
Drug: IN10018
Cohort B: JMKX001899+chemotherapy
Experimental group
Treatment:
Drug: JMKX001899
Drug: Chemotherapy: Pemetrexed
Drug: Carboplatin
Cohort C: JMKX001899+IN10018+chemotherapy
Experimental group
Treatment:
Drug: JMKX001899
Drug: Chemotherapy: Pemetrexed
Drug: Carboplatin
Drug: IN10018

Trial contacts and locations

1

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Central trial contact

Jieting Zhao

Data sourced from clinicaltrials.gov

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