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

Not Applicable

Not yet recruiting

• Conditions: Neoplasm Malignant
• Interventions: Drug: MK-1084; Biological: Cetuximab

• Registration Number: NCT07209111
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Study Start: 2025-11-24
• Primary Completion: 2032-04-09
• Study Completion: 2032-04-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-1084	MK-1084	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.
MK-1084 + Cetuximab	MK-1084	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.
MK-1084 + Cetuximab	Cetuximab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 76 months	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.
Objective Response Rate (ORR)	Up to approximately 76 months	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 76 months	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to approximately 76 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Duration of Response (DOR)	Up to approximately 76 months	For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Overall Survival (OS)	Up to approximately 76 months	OS is defined as the time from randomization to the date of death due to any cause. OS will be presented.