A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors

BeOne Medicines

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BGB-43395; Drug: BG-75098; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226349

BG-75098-101

2025-523165-19-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.

Full description

This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have measurable disease as assessed by RECIST v1.1.
• Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have adequate organ function.
• Dose Escalation Part A: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors potentially associated with cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior treatment with available standard-of-care (SOC) systemic therapies for advanced/metastatic disease, or for whom standard therapy is not available or not tolerated.
• Dose Escalation Part B: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line of systemic therapy in the metastatic setting.
• Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable CDK4/6 inhibitor-progressed solid tumors.
• Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with primary platinum refractory disease are not eligible. Participants should have received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic regimens in the advanced/metastatic setting.

Exclusion criteria

• For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation.
• For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4/6 inhibitor standard of care therapy is permitted and required in local regions where it is approved and available.
• Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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105 participants in 4 patient groups

Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy.

Treatment:

Drug: BG-75098

Phase 1a, Part B: Dose Escalation, BG-75098 Combination

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant.

Treatment:

Drug: Fulvestrant

Drug: BG-75098

Drug: BGB-43395

Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination

Experimental group

Description:

Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant.

Treatment:

Drug: Fulvestrant

Drug: BG-75098

Drug: BGB-43395

Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy

Experimental group

Description:

Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a.

Treatment:

Drug: BG-75098