marked.bio

KRAS G12C inhibitor (OFF state) · small molecule

calderasib

10 active trials across 3 of our biomarkers, targeting KRAS G12C. Not approved for any biomarker on marked.bio yet.

Also known as MK-1084.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
KRAS G12C 10 10 Phase 3
KRAS G12D 2 2 Phase 1/2
MSI-H / dMMR 1 1 Phase 1

Sponsors

Industry sponsors leading active biomarker-selected trials of calderasib.

  1. MSD (Merck & Co.) 10

Trials

10 of 10 trials shown

  1. A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

    Recruiting Phase 3 MSD (Merck & Co.) Started 2026Primary completion 2032-12 NCT07554339

    calderasibdurvalumab

    …rvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platin…

    KRAS G12CNon-small Cell Lung Cancer

  2. MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

    Recruiting Phase 3 MSD (Merck & Co.) Started 2026Primary completion 2039-10 NCT07431827

    calderasibpembrolizumab

    Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation

    KRAS G12CNon-small Cell Lung Cancer

  3. A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

    Recruiting Phase 3 MSD (Merck & Co.) Started 2025Primary completion 2029-03 NCT06997497

    calderasiboxaliplatinleucovorinfluorouracilcetuximabbevacizumab

    Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation

    KRAS G12CColon Adenocarcinoma, Rectal Adenocarcinoma

  4. A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

    Recruiting Phase 3 MSD (Merck & Co.) Started 2025Primary completion 2029-12 NCT07190248

    calderasibpembrolizumabpemetrexedcisplatincarboplatin

    …inum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

    KRAS G12CNon-small Cell Lung Cancer

  5. 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)

    Recruiting Phase 3 MSD (Merck & Co.) Started 2024Primary completion 2028-01 NCT06345729

    calderasibpembrolizumab

    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) Tum…

    KRAS G12CNon-small Cell Lung Cancer

  6. A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

    Recruiting Phase 1/2 MSD (Merck & Co.) Started 2026Primary completion 2029-08 NCT07286149

    calderasibpatritumab deruxtecansacituzumab tirumotecancetuximabRescue Medications

    …of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations

    KRAS G12CKRAS G12DLung Neoplasm Malignant

  7. KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)

    Recruiting Phase 2 MSD (Merck & Co.) Started 2025Primary completion 2029-11 NCT07252739

    calderasibpembrolizumabcetuximabsacituzumab tirumotecanRescue medication

    …cid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations

    KRAS G12CMalignant Neoplasm

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

    Recruiting Phase 2 MSD (Merck & Co.) Started 2025Primary completion 2032-04 NCT07209111

    calderasibcetuximab

    Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

    KRAS G12CNeoplasm Malignant

  9. Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

    Active, not recruiting Phase 1 MSD (Merck & Co.) Started 2023Primary completion 2028-06 NCT05853367

    MK-0472pembrolizumabcalderasib

    …histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation

    KRAS G12CMSI-H / dMMRMetastatic Solid Tumors, Advanced Solid Tumors

  10. A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

    Recruiting Phase 1 MSD (Merck & Co.) Started 2021Primary completion 2030-02 NCT05067283

    calderasibpembrolizumabcarboplatinpemetrexedcetuximaboxaliplatinleucovorinfluorouracil

    …e 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

    KRAS G12CKRAS G12DAdvanced Solid Tumors