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NCT Number: NCT07226349

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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG-75098

Drug

Administered orally.

BGB-43395

Drug

Administered orally.

Fulvestrant

Drug

Administered by intramuscular injection.

Primary outcomes

  1. 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

    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.

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098

    Time frame: Up 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.

  3. 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

    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.

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

    Time frame: Up 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.

Secondary outcomes

  1. Phase 1a: ORR as Assessed by the Investigator

    Time frame: Up to approximately 2 years

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

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

    Time frame: Up to approximately 2 years

    DOR is defined as the time from the first confirmed objective response assessed by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.

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

    Time frame: Up to approximately 2 years

    TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1.

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

    Time frame: Up to approximately 2 years

    PFS is defined as the time from the date of the first dose of study treatment to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.

  5. Phase 1b: DOR as Assessed by the Investigator

    Time frame: Up to approximately 2 years

    DOR is defined as the time from the first confirmed objective response assessed by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.

  6. Phase 1b: TTR as Assessed by the Investigator

    Time frame: Up to approximately 2 years

    TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1.

  7. Phase 1b: Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

    DCR is defined as the percentage of participants with a best overall response, of CR, PR, or stable disease assessed by the investigator using RECIST v1.1.

  8. Phase 1b: Clinical Benefit Rate (CBR)

    Time frame: Up to approximately 2 years

    CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.

  9. Phase 1b: PFS

    Time frame: Up to approximately 2 years

    PFS is defined as the time from the date of the first dose of study treatment to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.

  10. Phase 1b: Number of Participants with AEs

    Time frame: Up to approximately 2 years

    Number of participants with TEAEs and SAEs, including physical examination findings, electrocardiogram results, and laboratory values.

  11. Observed Plasma Maximum Concentration (Cmax) of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  12. Observed Plasma Trough Concentration (Ctrough) of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  13. Area Under the Concentration-Time Curve (AUC) of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  14. Terminal Half-Life (t1/2) of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  15. Phase 1b: Plasma Concentrations of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)

  16. Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  17. Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  18. Phase 1a: Area Under the Concentration-Time Curve (AUC) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  19. Phase 1a: Terminal Half-Life (t1/2) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  20. Plasma Concentrations of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

8778285568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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