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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05358249
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • JDQ443 — DRUG
    KRAS G12C inhibitor, oral
  • trametinib — DRUG
    MEK inhibitor, oral
  • Ribociclib — DRUG
    CDK4/6 inhibitor, oral
  • cetuximab — BIOLOGICAL
    EGFR inhibitor, intravenous

Study Details

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.

Key Dates

Start date
Oct 24, 2022
Status verified
Apr 2026
Primary completion
Jul 29, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
74 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JDQ443+trametinib
    JDQ443 in combination with trametinib
  • Experimental: JDQ443+ribociclib
    JDQ443 in combination with ribociclib
  • Experimental: JDQ443+cetuximab
    JDQ443 in combination with cetuximab

Primary Outcome Measure

Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) of each combination treatment. [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
NYU School of MedicineNew YorkNew York10015-

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By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MANYU School of Medicine· New York, NY

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