Calderasib

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Non-Small Cell Lung CancerColorectal CancerAdvanced Solid TumorsColon AdenocarcinomaNeoplasm Malignant

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

1

Calderasib

Merck & Co.

Phase 3

42

Vizimpro

Pfizer

Preclinical

43

Gilotrif

Boehringer Ingelheim

Preclinical

124

Immunotherapy

Bristol-Myers Squibb

Preclinical

125

Remeron

OOrganon and Co

Preclinical

16

PD-1 Inhibitor

Johnson & Johnson

Preclinical

27

Tyrosine Kinase Inhibitor

Pfizer

Preclinical

28

Treatment

GSK

Preclinical

19

Vidaza

Bristol-Myers Squibb

Preclinical

110

REGN2810

Regeneron

Preclinical

1Show 20 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

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·Merck & Co.·Phase 3·NCT06345729·600 enrolled

A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)

Recruiting·Merck & Co.·Phase 3·NCT07431827·400 enrolled

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Recruiting·Merck & Co.·Phase 3·NCT07190248·675 enrolled

Show 1 more trial

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Recruiting·Merck & Co.·Phase 3·NCT07554339·310 enrolled

Adult3 trials

A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)

Completed·Merck & Co.·Phase 1·NCT06942741·52 enrolled

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)

Completed·Merck & Co.·Phase 1·NCT06619314·56 enrolled

A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)

Completed·Merck & Co.·Phase 1·NCT06719557·28 enrolled

Hepatic Impairment1 trial

A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

Recruiting·Merck & Co.·Phase 1·NCT07219550·58 enrolled

Metformin1 trial

A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)

Completed·Merck & Co.·Phase 1·NCT07222098·16 enrolled

Midazolam1 trial

A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)

Completed·Merck & Co.·Phase 1·NCT06575933·28 enrolled

4 more indications

Renal Impairment1 trial

A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)

Completed·Merck & Co.·Phase 1·NCT06814119·34 enrolled

Colon Adenocarcinoma1 trial

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Recruiting·Merck & Co.·Phase 3·NCT06997497·477 enrolled

Neoplasm Malignant1 trial

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)

Recruiting·Merck & Co.·Phase 2·NCT07209111·150 enrolled

Advanced Solid Tumors1 trial

A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors

Recruiting·Merck & Co.·Phase 1·NCT05067283·830 enrolled

Details

Drug Info

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