A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07209111
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasm Malignant

Eligibility Criteria

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

Interventions

  • Calderasib — DRUG
    Oral administration
  • Cetuximab — BIOLOGICAL
    Intravenous administration

Study Details

Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation. The goals of this study are to learn: * How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.

Key Dates

Start date
Dec 4, 2025
Status verified
Jun 2026
Primary completion
Apr 9, 2032
Completion
Apr 9, 2032

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Calderasib
    Participants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
  • Experimental: Calderasib + Cetuximab
    Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m\^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 76 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Greater Baltimore Medical Center ( Site 1104)BaltimoreMaryland21204
Study Coordinator
443-849-3285
START Midwest ( Site 1103)Grand RapidsMichigan49546
Study Coordinator
616-389-1808
Comprehensive Cancer Centers of Nevada ( Site 1109)Las VegasNevada89169
Study Coordinator
702-952-3400
Rutgers Cancer Institute of New Jersey ( Site 1100)New BrunswickNew Jersey08903
Study Coordinator
732-235-3443
START Mountain Region ( Site 1106)West Valley CityUtah84119
Study Coordinator
210-593-5250
Virginia Cancer Specialists ( Site 1102)FairfaxVirginia22031
Study Coordinator
703-208-9268

Find similar trials in Baltimore, MD

By research site
Greater Baltimore Medical Center· Baltimore, MDSTART Midwest· Grand Rapids, MIComprehensive Cancer Centers of Nevada· Las Vegas, NVRutgers Cancer Institute of New Jersey· New Brunswick, NJSTART Mountain Region· West Valley City, UTVirginia Cancer Specialists· Fairfax, VA

Related Studies