A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Advanced Ovarian Cancer; Advanced Solid Tumor; Advanced Breast Cancer

Treatments: Drug: Palbociclib; Drug: BMS-986500; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06997029

CA243-0001

Details and patient eligibility

About

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be ≥ 18 years of age.
• Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
• Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• For Part 2A only, participants must have CCNE1-amplified ovarian cancer

Exclusion criteria

• Participants must not have an active brain metastasis.
• Participants must not have impaired cardiac function or clinically significant cardiac disease.
• Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
• Participants must not have Grade ≥ 2 peripheral neuropathy.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 5 patient groups

Part 1A Monotherapy Dose Escalation

Experimental group

Treatment:

Drug: BMS-986500

Part 1B Combination Dose Escalation

Experimental group

Treatment:

Drug: Fulvestrant

Drug: BMS-986500

Drug: Palbociclib

Part 1C Monotherapy Pharmacodynamic (PD) Sub-study

Experimental group

Treatment:

Drug: BMS-986500

Part 2A Monotherapy Dose Expansion

Experimental group

Treatment:

Drug: BMS-986500

Part 2B Combination Dose Expansion

Experimental group

Treatment:

Drug: Fulvestrant

Drug: BMS-986500

Drug: Palbociclib