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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Neoplasm Malignant

Treatments: Biological: Cetuximab; Drug: Calderasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07209111

MK-1084-014 (Other Identifier)

jRCT2031250825 (Registry Identifier)

2025-521737-91-00 (Registry Identifier)

U1111-1320-8626 (Registry Identifier)

1084-014

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Calderasib

Experimental group

Description:

Participants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Treatment:

Drug: Calderasib

Calderasib + Cetuximab

Experimental group

Description:

Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m\^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Treatment:

Biological: Cetuximab

Drug: Calderasib