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NCT Number: NCT07222267

An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.

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Key information

Conditions

Breast Cancer Advanced Solid Tumor Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

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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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies.
  • Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload).
  • Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.
  • Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
  • Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate organ function.

Exclusion criteria

  • Prior exposure to KAT6A/B or KAT7 inhibitors/degraders.
  • Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  • Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.

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

Treatment and study plan

BG-75202

Drug

Administered orally.

CDK4 Inhibitor

Drug

Administered orally.

Estrogen Receptor Antagonist

Drug

Administered by intramuscular injection.

Aromatase Inhibitor

Drug

Administered orally.

Primary outcomes

  1. Part 1: Number of Participants with Adverse Events (AEs)

    Time frame: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, 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. Part 1: Recommended Dose for Expansion (RDFE)

    Time frame: Estimated approximately 1 year

    The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data.

  3. Part 2: Overall Response Rate (ORR)

    Time frame: Up to approximately 2 years

    ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Secondary outcomes

  1. Part 1: ORR

    Time frame: Up to approximately 1 year

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

  2. Part 1: Duration of Response (DOR)

    Time frame: Up to approximately 1 year

    DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.

  3. Part 1: Time to Response (TTR)

    Time frame: Up to approximately 1 year

    TTR is defined as the time from treatment initiation to the first determination of objective response.

  4. Part 2: DOR

    Time frame: Up to approximately 2 years

    DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.

  5. Part 2: TTR

    Time frame: Up to approximately 2 years

    TTR is defined as the time from treatment initiation to the first determination of objective response.

  6. Part 2: Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

    DCR is defined as the percentage of participants who achieve CR, PR, or stable disease as assessed by investigator's review.

  7. Part 2: Clinical Benefit Rate (CBR)

    Time frame: Up to approximately 2 years

    CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks).

  8. Part 2: Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

    PFS is defined as the time from the date of the first dose of study treatment(s) to the date of the first documentation of disease progression assessed by investigator's review or death, whichever occurs first.

  9. Part 2: Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 2 years

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, and laboratory values.

  10. Part 2: Recommended Phase 2 Dose (RP2D)

    Time frame: Up to approximately 2 years

    The RP2D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.

  11. Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202

    Time frame: Up to approximately 4 months

  12. Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202

    Time frame: Up to approximately 4 months

  13. Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202

    Time frame: Up to approximately 4 months

  14. Parts 1 and 2: Terminal Half-Life (t1/2) of BG-75202

    Time frame: Up to approximately 4 months

Study contacts

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

Study Director

CONTACT

[email protected]

877-828-5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2029
Study completion
2037
First posted
Oct 29, 2025
Registry last updated
Jul 23, 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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