Recruiting
Phase 2

MK-1084 & Cetuximab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07209111

Conditions

Neoplasm Malignant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calderasib

Cetuximab

Study Details

Brief summary:

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.

Conditions

Neoplasm Malignant

Study ID

NCT07209111

Start date

Dec 4, 2025

Status verified date

Aug, 2026

Completion date

Apr 9, 2032

Anticipated

Primary completion date

Apr 9, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
  • Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
  • Has active infection, other than those permitted per protocol, requiring systemic therapy
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Calderasib

Oral administration

Cetuximab

Intravenous administration

Primary outcome measure

  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 76 months ]
  • Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 76 months ]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 76 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Greater Baltimore Medical Center ( Site 1104)

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Study Coordinator

443-849-3285

START Midwest ( Site 1103)

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Study Coordinator

616-389-1808

Comprehensive Cancer Centers of Nevada ( Site 1109)

Recruiting

Las Vegas, Nevada, United States, 89169

Contacts

Study Coordinator

702-952-3400

Rutgers Cancer Institute of New Jersey ( Site 1100)

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Study Coordinator

732-235-3443

START Mountain Region ( Site 1106)

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Study Coordinator

210-593-5250

Virginia Cancer Specialists ( Site 1102)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

703-208-9268

The Ottawa Hospital ( Site 2902)

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Study Coordinator

613-737-7700

Jewish General Hospital-CRU ( Site 2900)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • KRAS
  • NSCLC
  • CRC
  • Tumor-agnostic
  • Pan Tumor
  • KRAS G12C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-21.