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

Official title

A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

Overview

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.

Interventions

• Drug Calderasib
  Oral administration
• Biological Cetuximab
  Intravenous administration

Primary outcome measures

• 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]

Secondary outcome measures (3)

• Progression-free Survival (PFS) [Time frame: Up to approximately 76 months]
• Duration of Response (DOR) [Time frame: Up to approximately 76 months]
• Overall Survival (OS) [Time frame: Up to approximately 76 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 15 centers

• Beijing Cancer hospital ( Site 1318) — Beijing
• The First Affiliated Hospital of Xiamen University ( Site 1304) — Xiamen
• Sun Yat-sen University Cancer Center ( Site 1303) — Guangzhou
• The first affiliated hospital, Sun Yat-Sen university ( Site 1329) — Guangzhou
• Harbin Medical University Cancer Hospital ( Site 1308) — Harbin
• Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site — Wuhan
• Hunan Cancer Hospital ( Site 1321) — Changsha
• Jiangsu Province Hospital ( Site 1324) — Nanjing
• … and 7 more centers

United States · 6 centers

• Greater Baltimore Medical Center ( Site 1104) — Baltimore
• START Midwest ( Site 1103) — Grand Rapids
• Comprehensive Cancer Centers of Nevada ( Site 1109) — Las Vegas
• Rutgers Cancer Institute of New Jersey ( Site 1100) — New Brunswick
• START Mountain Region ( Site 1106) — West Valley City
• Virginia Cancer Specialists ( Site 1102) — Fairfax

Turkey (Türkiye) · 5 centers

• Adana Medical Park Seyhan Hastanesi ( Site 2706) — Adana
• Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702) — Ankara
• Ankara Bilkent Şehir Hastanesi ( Site 2701) — Ankara
• Hacettepe Universitesi-oncology hospital ( Site 2700) — Ankara
• Koc University Hospital ( Site 2704) — Istanbul

Chile · 4 centers

• FALP ( Site 1200) — Santiago
• Centro de Oncología de Precisión ( Site 1202) — Santiago
• Clinica San Carlos de Apoquindo ( Site 1203) — Santiago
• Bradfordhill ( Site 1201) — Santiago

Japan · 4 centers

• Kanagawa Cancer Center ( Site 2002) — Yokohama
• National Cancer Center Hospital ( Site 2000) — Chūō
• Cancer Institute Hospital of JFCR ( Site 2003) — Koto
• Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2004) — Osaka

Spain · 4 centers

• Hospital Virgen de la Victoria ( Site 2403) — Málaga
• Hospital Universitari Vall d Hebron ( Site 2401) — Barcelona
• Hospital Clinic de Barcelona ( Site 2402) — Barcelona
• Hospital Clinico San Carlos ( Site 2404) — Madrid

Australia · 3 centers

• Prince of Wales Hospital-Medical Oncology ( Site 1003) — Randwick
• Westmead Hospital ( Site 1000) — Westmead
• Epworth Freemasons ( Site 1004) — Melbourne

Germany · 3 centers

• Universitätsklinikum Leipzig ( Site 1602) — Leipzig
• Universitätsklinikum Jena ( Site 1603) — Jena
• Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1604) — Berlin

Israel · 3 centers

• Emek Medical Center ( Site 1800) — Afula
• Hadassah Medical Center ( Site 1801) — Jerusalem
• Sourasky Medical Center ( Site 1802) — Tel Aviv

Italy · 3 centers

• Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902) — Rozzano
• Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Si — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901) — Roma

Poland · 3 centers

• MTZ Clinical Research powered by Pratia ( Site 2205) — Warsaw
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200) — Warsaw
• Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203) — Koszalin

South Korea · 3 centers

• Seoul National University Hospital ( Site 2301) — Seoul
• Asan Medical Center ( Site 2302) — Seoul
• Samsung Medical Center ( Site 2300) — Seoul

Canada · 2 centers

• The Ottawa Hospital ( Site 2902) — Ottawa
• Jewish General Hospital-CRU ( Site 2900) — Montreal

Denmark · 2 centers

• Rigshospitalet ( Site 1403) — Copenhagen
• Odense Universitetshospital ( Site 1401) — Odense

France · 2 centers

• Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1503) — Limoges
• Hopital Pitie Salpetriere ( Site 1500) — Paris

Greece · 2 centers

• General Hospital of Athens "Laiko" ( Site 1701) — Athens
• European Interbalkan Medical Center-Oncology Department ( Site 1700) — Thessaloniki

Norway · 2 centers

• Haukeland universitetssykehus ( Site 2102) — Bergen
• Oslo universitetssykehus, Radiumhospitalet ( Site 2101) — Oslo

Sweden · 2 centers

• Karolinska Universitetssjukhuset Solna ( Site 2501) — Stockholm
• Sahlgrenska Universitetssjukhuset. ( Site 2502) — Gothenburg

United Kingdom · 2 centers

• Royal Free Hospital ( Site 2801) — London
• The Christie NHS Foundation Trust ( Site 2803) — Manchester

Identifiers

NCT: NCT07209111 · 1084-014 · MK-1084-014 · U1111-1320-8626 · 2025-521737-91-00 · jRCT2031250825

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗