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

ClinicalTrials.gov ID

NCT07209111

Lead Sponsor

Merck Sharp & Dohme LLCINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

150Estimated

Last Update Posted

Aug 21, 2026Actual

Start Date

Dec 4, 2025Actual

Primary Completion Date

Apr 9, 2032Estimated

Completion Date

Apr 9, 2032Estimated

Official Title

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)

Brief Summary

Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.

The goals of this study are to learn:

• How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare
• About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.

• Neoplasm Malignant

• Calderasib
• Cetuximab

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
• Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
• Has active infection, other than those permitted per protocol, requiring systemic therapy
• Has not adequately recovered from major surgery or has ongoing surgical complications

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Merck Sharp & Dohme LLCINDUSTRY

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