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

NCT07209111 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 1084-014MK-1084-014U1111-1320-86262025-521737-91-00jRCT2031250825
• Study Type: interventional
• Target: 150
• Locations: 15 countries
• Sites: 50

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

  Up to approximately 76 months

• Number of Participants Who Experience One or More Adverse Events (AEs)

  An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.

  Up to approximately 76 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

  Up to approximately 76 months

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Up to approximately 76 months

• Duration of Response (DOR)

  Up to approximately 76 months

• Overall Survival (OS)

  Up to approximately 76 months

Study Arms (2)

Calderasib

EXPERIMENTAL

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.

Drug: Calderasib

Calderasib + Cetuximab

EXPERIMENTAL

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.

Drug: Calderasib; Biological: Cetuximab

Interventions

Cetuximab BIOLOGICAL

Intravenous administration

Calderasib + Cetuximab

Calderasib DRUG

Oral administration

Also known as: MK-1084

Calderasib; Calderasib + Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (50)

Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland, 21204, United States

RECRUITING

START Midwest ( Site 1103)

Grand Rapids, Michigan, 49546, United States

RECRUITING

Comprehensive Cancer Centers of Nevada ( Site 1109)

Las Vegas, Nevada, 89169, United States

RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 1100)

New Brunswick, New Jersey, 08903, United States

RECRUITING

START Mountain Region ( Site 1106)

West Valley City, Utah, 84119, United States

RECRUITING

Virginia Cancer Specialists ( Site 1102)

Fairfax, Virginia, 22031, United States

RECRUITING

Prince of Wales Hospital-Medical Oncology ( Site 1003)

Randwick, New South Wales, 2031, Australia

RECRUITING

Westmead Hospital ( Site 1000)

Westmead, New South Wales, 2145, Australia

RECRUITING

Beijing Cancer hospital ( Site 1318)

Beijing, Beijing Municipality, 100142, China

RECRUITING

The First Affiliated Hospital of Xiamen University ( Site 1304)

Xiamen, Fujian, 361003, China

RECRUITING

Sun Yat-sen University Cancer Center ( Site 1303)

Guangzhou, Guangdong, 510060, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)

Wuhan, Hubei, 430000, China

RECRUITING

Jiangsu Province Hospital ( Site 1324)

Nanjing, Jiangsu, 210029, China

RECRUITING

Jinan Central Hospital ( Site 1313)

Jinan, Shandong, 250013, China

RECRUITING

Shanghai Chest Hospital ( Site 1300)

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 1325)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital,Fudan University ( Site 1301)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhejiang Cancer Hospital ( Site 1311)

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang Province ( Site 1312)

Linhai, Zhejiang, 317000, China

RECRUITING

Rigshospitalet ( Site 1403)

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Odense Universitetshospital ( Site 1401)

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Universitätsklinikum Leipzig ( Site 1602)

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitätsklinikum Jena ( Site 1603)

Jena, Thuringia, 07747, Germany

RECRUITING

European Interbalkan Medical Center-Oncology Department ( Site 1700)

Thessaloniki, 57001, Greece

RECRUITING

Emek Medical Center ( Site 1800)

Afula, 1834111, Israel

RECRUITING

Hadassah Medical Center ( Site 1801)

Jerusalem, 9112001, Israel

RECRUITING

Sourasky Medical Center ( Site 1802)

Tel Aviv, 6423906, Israel

RECRUITING

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902)

Rozzano, Milano, 20089, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1900)

Milan, 20133, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901)

Roma, 00168, Italy

RECRUITING

Haukeland universitetssykehus ( Site 2102)

Bergen, Hordaland, 5021, Norway

RECRUITING

Oslo universitetssykehus, Radiumhospitalet ( Site 2101)

Oslo, 0379, Norway

RECRUITING

MTZ Clinical Research powered by Pratia ( Site 2205)

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

RECRUITING

Seoul National University Hospital ( Site 2301)

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center ( Site 2302)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 2300)

Seoul, 06351, South Korea

RECRUITING

Hospital Virgen de la Victoria ( Site 2403)

Málaga, Malaga, 29010, Spain

RECRUITING

Hospital Universitari Vall d Hebron ( Site 2401)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona ( Site 2402)

Barcelona, 08036, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 2404)

Madrid, 28040, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 2501)

Stockholm, Stockholm County, 171 64, Sweden

RECRUITING

Sahlgrenska Universitetssjukhuset. ( Site 2502)

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

Adana Medical Park Seyhan Hastanesi ( Site 2706)

Adana, 01140, Turkey (Türkiye)

RECRUITING

Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702)

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Hacettepe Universitesi-oncology hospital ( Site 2700)

Ankara, 6230, Turkey (Türkiye)

RECRUITING

Koc University Hospital ( Site 2704)

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Royal Free Hospital ( Site 2801)

London, Camden, NW3 2QG, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 2803)

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Neoplasms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 6, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): April 9, 2032
• Study Completion (Estimated): April 9, 2032
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (3); DE (2); IT (3); PL (3); AU (2); TU (4); DK (2); SE (2); IL (3); GB (2); US (6); NO (2); GR (1); CN (11); ES (4)