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

NCT07226349 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: BG-75098-1012025-523165-19-00
• Study Type: interventional
• Target: 105
• Locations: 4 countries
• Sites: 16

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Phase 1a: Number of Participants with Adverse Events (AEs)

  Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.

  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

  MTD is determined based on a target for dose-limiting toxicities. MAD is defined as the maximum administered dose, and it is used when MTD is not reached.

  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

  The RDFE(s) will be determined from safety, tolerability, pharmacokinetic, pharmacodynamic biomarker(s), preliminary antitumor activity, and any other relevant data that are obtained from the dose escalation phase.

  Up to approximately 2 years

• Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator

  ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (20)

• Phase 1a: ORR as Assessed by the Investigator

  Up to approximately 2 years

• Phase 1a: Duration of Response (DOR) as Assessed by the Investigator

  Up to approximately 2 years

• Phase 1a: Time to Response (TTR) as Assessed by the Investigator

  Up to approximately 2 years

• Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator

  Up to approximately 2 years

• Phase 1b: DOR as Assessed by the Investigator

  Up to approximately 2 years

Study Arms (4)

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

EXPERIMENTAL

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

Drug: BG-75098

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

Drug: BG-75098

Interventions

BG-75098 DRUG

Administered orally.

Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy; Phase 1a, Part B: Dose Escalation, BG-75098 Combination; Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination; Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy

BGB-43395 DRUG

Administered orally.

Phase 1a, Part B: Dose Escalation, BG-75098 Combination; Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination

Fulvestrant DRUG

Administered by intramuscular injection.

Phase 1a, Part B: Dose Escalation, BG-75098 Combination; Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (16)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, 35294-0004, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Next Houston

Houston, Texas, 77054, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Icon Cancer Centre Wesley

Auchenflower, Queensland, QLD 4066, Australia

RECRUITING

Cabrini Hospital Malvern

Malvern East, Victoria, VIC 3144, Australia

RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, Guangdong, 510245, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch

Wuhan, Hubei, 430048, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Weifang Peoples Hospital

Weifang, Shandong, 261000, China

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

8778285568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (7); AU (4); DK (1); US (4)