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Calderasib

DRUG11 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Advanced Solid TumorsColon AdenocarcinomaHealthyHepatic ImpairmentNeoplasm MalignantNon-small Cell Lung CancerRectal AdenocarcinomaRenal Impairment

Phase 1

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
RecruitingNCT05067283
Merck Sharp & Dohme LLCAdvanced Solid Tumors
Start: 2021-12-17End: 2030-02-25Target: 830Updated: 2026-02-12
A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
CompletedNCT06575933
Merck Sharp & Dohme LLCNon-small Cell Lung Cancer
Start: 2024-09-03End: 2024-10-28Updated: 2026-02-11
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-003)
CompletedNCT06619314
Merck Sharp & Dohme LLCHealthy
Start: 2023-09-20End: 2023-11-25Updated: 2026-02-11
A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)
CompletedNCT06719557
Merck Sharp & Dohme LLCHealthy
Start: 2024-05-20End: 2024-07-30Updated: 2026-02-11
A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)
CompletedNCT06814119
Merck Sharp & Dohme LLCHealthy, Renal Impairment
Start: 2025-04-07End: 2026-02-06Updated: 2026-02-13
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
RecruitingNCT07219550
Merck Sharp & Dohme LLCHealthy, Hepatic Impairment
Start: 2025-11-05End: 2026-08-14Target: 58Updated: 2026-03-05
A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)
CompletedNCT07222098
Merck Sharp & Dohme LLCHealthy
Start: 2025-11-19End: 2025-12-23Updated: 2026-02-11

Phase 2

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
RecruitingNCT07209111
Merck Sharp & Dohme LLCNeoplasm Malignant
Start: 2025-12-04End: 2032-04-09Target: 150Updated: 2026-04-03

Phase 3

A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
RecruitingNCT06345729
Merck Sharp & Dohme LLCNon-small Cell Lung Cancer
Start: 2024-05-24End: 2031-02-18Target: 600Updated: 2026-04-03
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
RecruitingNCT06997497
Merck Sharp & Dohme LLCColon Adenocarcinoma, Rectal Adenocarcinoma
Start: 2025-07-16End: 2030-10-27Target: 477Updated: 2026-04-03
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
RecruitingNCT07190248
Merck Sharp & Dohme LLCNon-small Cell Lung Cancer
Start: 2025-10-08End: 2032-08-06Target: 675Updated: 2026-04-03

Related Papers

Abstract 1008: Effect of the KRAS G12C inhibitor MK-1084 on circulating tumor DNA levels in participants with KRAS G12-mutated tumors
Cancer Research2026-04-03
140TiP KANDLELIT-007: Phase III, open-label study of first-line calderasib with subcutaneous pembrolizumab (pembro SC) vs pembro SC plus chemotherapy (chemo) for KRAS G12C– mutant advanced/metastatic nonsquamous NSCLC
ESMO Open2026-03-17
KANDLELIT-012: Phase 3 study of MK-1084 (a <i>KRAS G12C</i> inhibitor) plus cetuximab and mFOLFOX6 with or without bevacizumab for <i>KRAS</i> <i>G12C</i> -mutant colorectal cancer.
Journal of Clinical Oncology2026-01-10
MK-1084 for KRAS G12C-mutated (mut) metastatic non–small-cell lung cancer (mNSCLC): Results from KANDLELIT-001.
Journal of Clinical Oncology2025-05-285 citations
The KRAS G12C inhibitor MK-1084 for <i>KRAS</i> G12C–mutated advanced colorectal cancer (CRC): Results from KANDLELIT-001.
Journal of Clinical Oncology2025-05-284 citations
Discovery of MK-1084: An Orally Bioavailable and Low-Dose KRAS<sup>G12C</sup> Inhibitor
Journal of Medicinal Chemistry2024-06-2629 citations
44O Updated results from a phase I study evaluating the KRAS G12C inhibitor MK-1084 in solid tumors and in combination with pembrolizumab in NSCLC
ESMO Open2024-02-0112 citations
A phase 1, open-label, multicenter study evaluating MK-1084 as monotherapy and in combination with other therapies in patients with <i>KRAS</i> G12C mutant advanced solid tumors.
Journal of Clinical Oncology2024-01-205 citations