Recruiting
Phase 1

BG-75098, BGB-43395, Fulvestrant

Sponsor:

BeOne Medicines

Code:

NCT07226349

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BG-75098

BGB-43395

Fulvestrant

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Study ID

NCT07226349

Start date

Dec 11, 2025

Status verified date

Aug, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

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

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

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

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

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

Interventions

BG-75098

Administered orally.

BGB-43395

Administered orally.

Fulvestrant

Administered by intramuscular injection.

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) [ Time Frame: From first dose to 30 days after last dose, up to approximately 12 months ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098 [ Time Frame: Up to approximately 2 years ]
  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and Fulvestrant [ Time Frame: Up to approximately 2 years ]
  • Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Study Director

8778285568clinicaltrials@beonemed.com

Locations

University of Alabama At Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35294-0004

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Next Houston

Recruiting

Houston, Texas, United States, 77054

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3522

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Cyclin-Dependent Kinase 2- Targeted Protein Degrader
  • CDK2
  • CDK4
  • CDK4 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-19.