A Clinical Study of 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: Drug: MK-1084; Biological: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07209111

MK-1084-014 (Other Identifier)

2025-521737-91-00 (Registry Identifier)

U1111-1320-8626 (Registry Identifier)

1084-014

Details and patient eligibility

About

Researchers want to learn if MK-1084 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 MK-1084 alone or with cetuximab and how these responses compare
• About the safety of MK-1084 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

MK-1084

Experimental group

Description:

Participants will receive MK-1084 orally. Per protocol treatment of MK-1084 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Treatment:

Drug: MK-1084

MK-1084 + Cetuximab

Experimental group

Description:

Participants will receive MK-1084 orally. Participants will receive Cetuximab 500 mg/m\^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of MK-1084 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: MK-1084