A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06412198
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • KRAS G12C Mutations
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.

Key Dates

Start date
Aug 28, 2024
Status verified
Mar 2026
Primary completion
Mar 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
31 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lead-In
    Participants enrolled in the Lead-In phase, the dose of adagrasib participants receive will depend on when the participant join this study. The first group of participants will receive the starting dose level of adagrasib. If intolerable side effects are seen, a second group of participants will be enrolled to receive a lower dose. One (1) of these 2 doses will be chosen as the recommended dose of adagrasib.
  • Experimental: Expansion
    Participants enrolled in the Expansion phase, participants will receive adagrasib at the recommended dose that was found in the Lead-In phase.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Ryan Corcoran, MD
[email protected]
617-726-8599
Ryan Corcoran, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Christine Parseghian, MD
[email protected]
713-792-2828
Christine Parseghian, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital Cancer Center· Boston, MAMD Anderson Cancer Center· Houston, TX

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