A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.
Key facts
- Study ID
- NCT05067283
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 830
- Starts
- 2021-12-17
- Expected to finish
- 2030-02-25
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For all participants:
- Has measurable disease by RECIST 1.1 criteria
- Has adequate organ function
- Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic
- Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
- For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
- For Arm 2
- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
- For Arm 3
- Has locally advanced unresectable or metastatic solid-tumor malignancy with histological or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC
- Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample
- Previous treatment failure of at least 1 line of systemic therapy Expansion Group B
- Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
- Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
- Arm 5 only
- Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
- Previous treatment failure of one or 2 previous line(s) of systemic therapy
- Arm 6 only
- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
You may not qualify if…
- Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention
- Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
- Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active infection requiring systemic therapy
- Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection
- Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
- Has an active autoimmune disease requiring systemic therapy
- Has not fully recovered from any effects of major surgical procedure without significant detectable infection
- Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease excluding age-related macular degeneration
- Has received live or live-attenuated vaccine within 4 weeks of study start
- Arm 4 Only
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
- Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Where it is running
- Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415) — Guangzhou, Guangdong, China (enrolling)
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260) — Hackensack, New Jersey, United States (enrolling)
- Moffitt Cancer Center ( Site 0261) — Tampa, Florida, United States (enrolling)
- NEXT Virginia ( Site 0271) — Fairfax, Virginia, United States (enrolling)
- MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262) — Milwaukee, Wisconsin, United States (enrolling)
- Instituto Alexander Fleming ( Site 0434) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
- Sanatorio Parque ( Site 0456) — Rosario, Santa Fe Province, Argentina (enrolling)
- START Midwest ( Site 0267) — Grand Rapids, Michigan, United States (enrolling)
- Chris O'Brien Lifehouse ( Site 0002) — Camperdown, New South Wales, Australia (enrolling)
- Liverpool Hospital-Medical Oncology ( Site 0001) — Liverpool, New South Wales, Australia (enrolling)
- Westmead Hospital ( Site 0006) — Westmead, New South Wales, Australia (enrolling)
- Monash Health-Oncology Research ( Site 0003) — Clayton, Victoria, Australia (enrolling)
- Cross Cancer Institute ( Site 0033) — Edmonton, Alberta, Canada (enrolling)
- The Moncton Hospital ( Site 0037) — Moncton, New Brunswick, Canada (enrolling)
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030) — Hamilton, Ontario, Canada (enrolling)
- Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036) — Kingston, Ontario, Canada (enrolling)
- Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032) — Toronto, Ontario, Canada (enrolling)
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438) — La Rioja, Argentina (enrolling)
- Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041) — Santiago, Region M. de Santiago, Chile (enrolling)
- FALP-UIDO ( Site 0040) — Santiago, Region M. de Santiago, Chile (enrolling)
- Bradfordhill ( Site 0042) — Santiago, Region M. de Santiago, Chile (enrolling)
- Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417) — Beijing, Beijing Municipality, China (enrolling)
- Fujian Cancer Hospital ( Site 0419) — Fuzhou, Fujian, China (enrolling)
- Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413) — Guangzhou, Guangdong, China (enrolling)
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418) — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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