For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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:

  1. 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 therapy
  2. Patients 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:

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

EXCLUSION CRITERIA

Exclusion Criteria:

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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study Details


Contition

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

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

346

Est. Completion Date

Jun 16, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Novartis

ClinicalTrials.gov NCT Identifier

NCT05358249

Study Number

CJDQ443E12101

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