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A Study of BG-75098 for Advanced Solid Tumors

This study is testing BG-75098, alone and with BGB-43395 and fulvestrant, in adults with advanced solid tumors. The purpose is to understand how safe these treatments are, how well your body handles them, and if they show early signs of shrinking tumors. Researchers are looking at how BG-75098 affects CDK and CDK4. You might be able to join if you have advanced, metastatic, or unresectable solid tumors that can be measured, have a good general health status (ECOG 0 or 1), and healthy organ function. The study aims to find the safest and most effective dose of BG-75098. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 105 participants. It will be conducted in two parts: a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first dose to 30 days after your last dose, for up to approximately 12 months. The maximum tolerated dose and recommended dose will be assessed for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07226349

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~105 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:BG-75098BGB-43395Fulvestrant

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of Participants with Adverse Events (AEs)
Measured over From first dose to 30 days after last dose, up to approximately 12 months
+3 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT07226349

Where you'd take part

This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, Australiano site contact published

    Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria, Australiano site contact published

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Genesiscare St Leonards

    St Leonards, New South Wales, Australiano site contact published

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, Chinano site contact published

    Recruiting

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, Australiano site contact published

    Recruiting

  • Jiangsu Province Hospital Longjiang Branch

    Nanjing, Jiangsu, Chinano site contact published

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
8778285568
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Phase 1a: Number of Participants with Adverse Events (AEs)From first dose to 30 days after last dose, up to approximately 12 months

    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.

  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098Up to approximately 2 years

    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.

  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and FulvestrantUp to approximately 2 years

    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.

  • Phase 1b: Objective Response Rate (ORR) as Assessed by the InvestigatorUp to approximately 2 years

    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.