Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Trial number:
NCT05358249
Trial phase:
1, 2
Study type:
Targeted therapy, Biomarker
Overall status:
Recruiting

Study start date

October, 2022

Scientific title

KontRASt-03: A Phase Ib/II, Multicenter, Open-label Platform Study of JDQ443 With Select Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Summary

This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

Dose Escalation:

- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy.

Phase II:

Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapyPatients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.

All patients:

ECOG performance status of 0 or 1.Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.

Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutationsPrior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II. Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease Clinically significant cardiac disease or risk factors at screening Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply

Study design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Sequential Assignment, Masking: None (Open Label),

Conditions

KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Colorectal Tumors, Neoplasms, Colorectal

Other study ID numbers

CJDQ443E12101; 2021-006196-42

Choose trial site (7)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting