Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 2, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07492680). This is a study registration, not published results. Lead sponsor: Bristol-Myers Squibb. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 254 participants (ESTIMATED). Conditions: Solid Tumors. Interventions: DRUG: Navlimetostat; DRUG: Daraxonrasib; DRUG: Temozolomide; DRUG: Pumitamig; DRUG: Pemetrexed; DRUG: Carboplatin; DRUG: Nab-paclitaxel; DRUG: Gemcitabine; DRUG: Paclitaxel; DRUG: Cisplatin. Primary outcome measures: Part 1: Number of participants who achieve Objective Response (OR) , Up to approximately 2 years; Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria , Up to approximately 2 years; Part 2: Number of participants with adverse events (AE) , Up to approximately 2 years; Part 2: Number of participants with Serious AEs (SAEs) , Up to approximately 2 years; Part 2: Number of participants with treatment related AEs , Up to approximately 2 years; Part 2: Number of participants with treatment related SAEs , Up to approximately 2 years; Part 2: Number of participants with AEs leading to study treatment discontinuation , Up to approximately 2 years; Part 2: Number of participants with AEs leading to death , Up to approximately 2 years; Part 2: Number of participants with laboratory abnormalities , Up to approximately 2 years. Brief summary: This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (BMS-986504) in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which Navlimetostat (BMS-986504) is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Navlimetostat (BMS-986504) alone and in combination regimens.