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

NCT07209111 · tracked via the Priya Life Science Germany tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 2

Started

2025-12-04

Last updated

2026-08-21

Condition(s) studied

Neoplasm Malignant

Investigational drug(s) / intervention(s)

Calderasib →Cetuximab →

Calderasib: Oral administration

Cetuximab: Intravenous administration

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Objective Response Rate (ORR) — Up to approximately 76 months
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.
Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 76 months
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.
Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 76 months
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.

Trial sites (71)

Facility	City	Region	Status
Greater Baltimore Medical Center ( Site 1104)	Baltimore	Maryland	Recruiting
START Midwest ( Site 1103)	Grand Rapids	Michigan	Recruiting
Comprehensive Cancer Centers of Nevada ( Site 1109)	Las Vegas	Nevada	Recruiting
Rutgers Cancer Institute of New Jersey ( Site 1100)	New Brunswick	New Jersey	Recruiting
START Mountain Region ( Site 1106)	West Valley City	Utah	Recruiting
Virginia Cancer Specialists ( Site 1102)	Fairfax	Virginia	Recruiting
Prince of Wales Hospital-Medical Oncology ( Site 1003)	Randwick	New South Wales	Recruiting
Westmead Hospital ( Site 1000)	Westmead	New South Wales	Recruiting
Epworth Freemasons ( Site 1004)	Melbourne	Victoria	Recruiting
The Ottawa Hospital ( Site 2902)	Ottawa	Ontario	Recruiting
Jewish General Hospital-CRU ( Site 2900)	Montreal	Quebec	Recruiting
FALP ( Site 1200)	Santiago	Region M. de Santiago	Recruiting
Centro de Oncología de Precisión ( Site 1202)	Santiago	Region M. de Santiago	Recruiting
Clinica San Carlos de Apoquindo ( Site 1203)	Santiago	Region M. de Santiago	Recruiting
Bradfordhill ( Site 1201)	Santiago	Region M. de Santiago	Recruiting
Beijing Cancer hospital ( Site 1318)	Beijing	Beijing Municipality	Recruiting
The First Affiliated Hospital of Xiamen University ( Site 1304)	Xiamen	Fujian	Recruiting
Sun Yat-sen University Cancer Center ( Site 1303)	Guangzhou	Guangdong	Recruiting
The first affiliated hospital, Sun Yat-Sen university ( Site 1329)	Guangzhou	Guangdong	Recruiting
Harbin Medical University Cancer Hospital ( Site 1308)	Harbin	Heilongjiang	Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326)	Wuhan	Hubei	Recruiting
Hunan Cancer Hospital ( Site 1321)	Changsha	Hunan	Recruiting
Hunan Cancer Hospital ( Site 1322)	Changsha	Hunan	Recruiting
Jiangsu Province Hospital ( Site 1324)	Nanjing	Jiangsu	Recruiting
The First Affiliated Hospital of Nanchang University ( Site 1307)	Nanchang	Jiangxi	Recruiting
Jinan Central Hospital ( Site 1313)	Jinan	Shandong	Recruiting
Shanghai Chest Hospital ( Site 1300)	Shanghai	Shanghai Municipality	Recruiting
Fudan University Shanghai Cancer Center ( Site 1325)	Shanghai	Shanghai Municipality	Recruiting
Zhongshan Hospital,Fudan University ( Site 1301)	Shanghai	Shanghai Municipality	Recruiting
Zhejiang Cancer Hospital ( Site 1311)	Hangzhou	Zhejiang	Recruiting
Taizhou Hospital of Zhejiang Province ( Site 1312)	Linhai	Zhejiang	Recruiting
Rigshospitalet ( Site 1403)	Copenhagen	Capital Region	Recruiting
Odense Universitetshospital ( Site 1401)	Odense	Region Syddanmark	Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1503)	Limoges	Haute-Vienne	Recruiting
Hopital Pitie Salpetriere ( Site 1500)	Paris	France	Recruiting
Universitätsklinikum Leipzig ( Site 1602)	Leipzig	Saxony	Recruiting
Universitätsklinikum Jena ( Site 1603)	Jena	Thuringia	Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1604)	Berlin	Germany	Recruiting
General Hospital of Athens "Laiko" ( Site 1701)	Athens	Attica	Recruiting
European Interbalkan Medical Center-Oncology Department ( Site 1700)	Thessaloniki	Greece	Recruiting

+ 31 more sites — see the full list on the official registry below.

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Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) Active, not recruiting

A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008) Recruiting

Other trials for the same condition

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07209111 on ClinicalTrials.gov ↗ ← All trials in Germany