A Study of MK-1084 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With KRASG12C Mutant Advanced Solid Tumors (MK-1084-001)

• Status: Not yet recruiting
• Trial end date: 2026-02-05
• Target enrollment: 0
• Participant gender: All

Summary

This is a study evaluating the efficacy, safety, and pharmacokinetics of MK-1084 in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRASG12C) mutation and MK-1084 plus pembrolizumab in participants with first line (1L) non-small cell lung cancer (NSCLSC) with identified KRASG12C mutation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

For treatment with MK-1084 - Has metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRASG12C mutation who has received at least 1 line of therapy for systemic disease.

For treatment with pembrolizumab plus MK-1084

• Has an untreated metastatic NSCLC with histological OR blood-based confirmation of KRASG12C mutation and histologic confirmation of tumor proportion score (TPS) ≥1%.

For all participants:

• Has measurable disease by RECIST 1.1 criteria.

• Has adequate organ function.

• Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic.

• Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention.

Exclusion Criteria:

• Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation).

• Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years.

• Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Has an active infection requiring systemic therapy.

• Has a history of human immunodeficiency virus (HIV) and/or hepatitis B or C infections.

• Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.

• Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis.

• Has an active autoimmune disease requiring systemic therapy.

• Has not fully recovered from any effects of major surgical procedure without significant detectable infection.

• Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease.

• Has received live or live-attenuated vaccine within 4 weeks of study start.