Calderasib

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

7 competitors in Neoplasm Malignant

#DrugCompanyPhaseTrials

1

Keytruda

Merck & Co.

Approved

12

Eloxatin

Teva

Approved

13

Gemzar

Johnson & Johnson

Approved

14

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

15

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Approved

16

5-Fluorouracil

Merck & Co.

Phase 3

17

Erbitux

IImclone

Phase 2

18

Calderasib

Merck & Co.

Phase 2

1

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 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

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, 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

Show 1 more trial

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

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

Adult3 trials

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

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

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

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

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

Solid Tumor1 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

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

Hepatic Impairment1 trial

A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084

Completed·Merck & Co.·Phase 1·NCT07219550·32 enrolled

Details

Drug Info

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