For Healthcare Professionals

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

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About the study

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.
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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:

  1. Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
  2. ECOG Performance Status of 0 or 1
  3. At least one measurable lesion as defined by RECIST 1.1
  4. Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
  2. Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
  3. Clinically significant cardiac disease or risk factors at screening
  4. A medical condition that results in increased photosensitivity 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’s details


Contition

Carcinoma, Non-Small-Cell Lung,KRAS G12C Mutant Solid Tumors,Carcinoma, Colorectal,Cancer of Lung,Cancer of the Lung,Lung Cancer,Neoplasms, Lung,Neoplasms, Pulmonary,Pulmonary Cancer,Pulmonary Neoplasms

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

475

Est. Completion Date

Jan 8, 2027

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT04699188

Study number

CJDQ443A12101

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