A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ovarian Neoplasms; Melanoma; Carcinoma, Renal Cell; Gastric/Gastroesophageal Junction Adenocarcinoma; Pancreatic Adenocarcinoma; Urothelial Carcinoma; Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Neoplasms; Microsatellite Stable Colorectal Cancer; Non-Small-Cell Lung Cancer; Cervical Cancer

Treatments: Drug: BMS-986340; Drug: BMS-936558-01; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04895709

2023-503651-10 (Registry Identifier)

U1111-1265-4508 (Registry Identifier)

CA052-002

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Enrollment: 905 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Radiographically documented progressive disease on or after the most recent therapy
• Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
• Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Exclusion criteria

• Women who are pregnant or breastfeeding
• Primary central nervous system (CNS) malignancy
• Untreated CNS metastases
• Leptomeningeal metastases
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
• Active, known, or suspected autoimmune disease
• Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
• Prior organ or tissue allograft
• Uncontrolled or significant cardiovascular disease
• Major surgery within 4 weeks of study drug administration
• History of or with active interstitial lung disease or pulmonary fibrosis

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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905 participants in 5 patient groups

Part 1A: BMS-986340 Dose Escalation

Experimental group

Treatment:

Drug: BMS-986340

Part 2A: BMS-986340 Dose Expansion

Experimental group

Treatment:

Drug: BMS-986340

Part 1B: BMS-986340 + Nivolumab Dose Escalation

Experimental group

Treatment:

Drug: BMS-936558-01

Drug: BMS-986340

Part 2B: BMS-986340 + Nivolumab Dose Expansion

Experimental group

Treatment:

Drug: BMS-936558-01

Drug: BMS-986340

Part 1C: BMS-986340 + Docetaxel Dose Escalation

Experimental group

Treatment:

Drug: Docetaxel

Drug: BMS-986340