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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 - ECOG Performance Status of 0 or 1 - At least one measurable lesion as defined by RECIST 1.1 - 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

  • Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations - Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible - Clinically significant cardiac disease or risk factors at screening - A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		JDQ443
  • Drug: JDQ443
    KRAS G12C inhibitor
Experimental
Arm B 		JDQ443 in combination with TNO155
  • Drug: JDQ443
    KRAS G12C inhibitor
  • Drug: TNO155
    SHP2 inhibitor
Experimental
Arm C 		JDQ443 in combination with tislelizumab
  • Drug: JDQ443
    KRAS G12C inhibitor
  • Biological: tislelizumab
    Anti PD1 antibody
Experimental
Arm D 		JDQ443 in combination with TNO155 and tislelizumab
  • Drug: JDQ443
    KRAS G12C inhibitor
  • Drug: TNO155
    SHP2 inhibitor
  • Biological: tislelizumab
    Anti PD1 antibody

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Rebecca Heist
rheist@partners.org

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.