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Recruiting

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors - CA234-0001

Atualizado: 2 abril, 2025   |   ClinicalTrials.gov

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Detalhes do estudo

  • Phase 1

    Fase

  • Gênero(s)

  • 18+

    Faixa etária

  • 8

    Localização(ões)

  • Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Part 1A: BMS-986488 Monotherapy
Drug: BMS-986488
Experimental: Part 1B: BMS-986488 + Adagrasib
Drug: BMS-986488, Adagrasib
Experimental: Part 1C: BMS-986488 + Adagrasib + Cetuximab
Drug: BMS-986488, Adagrasib, Cetuximab
Experimental: Part 1D: BMS-986488 + Nivolumab
Drug: BMS-986488, Nivolumab
Experimental: Part 2A: BMS-986488 Monotherapy
Drug: BMS-986488
Experimental: Part 2B: BMS-986488 + Adagrasib
Drug: BMS-986488, Adagrasib
Experimental: Part 2C: BMS-986488 + Adagrasib + Cetuximab
Drug: BMS-986488, Adagrasib, Cetuximab
Experimental: Part 2D: BMS-986488 + Nivolumab
Drug: BMS-986488, Nivolumab

Principais critérios de elegibilidade

Inclusion Criteria: - Participant must be ≥ 18 years of age. - Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. - Part 1A: clear-cell renal cell carcinoma (ccRCC) or clear-cell ovarian cancer (ccOC). - Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation. ii) Part 2B: NSCLC with KRAS G12C mutation. iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation. - Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1. - Participants must have measurable disease per RECIST v1.1. Exclusion Criteria: - Untreated central nervous system (CNS) metastases. - Leptomeningeal metastasis (carcinomatous meningitis). - Impaired cardiac function or clinically significant cardiac disease. - For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD). ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). - Other protocol-defined inclusion/exclusion criteria apply.

É altamente recomendável que você entre em contato com a BMS para relatar efeitos colaterais (eventos adversos).
Efeitos colaterais (eventos adversos) e outros eventos relatáveis estão definidos aqui.
Relate efeitos colaterais (eventos adversos) ou reclamações sobre a qualidade do produto: Informações médicas

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