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

November 9, 2026 updated by: BeOne Medicines

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will enroll participants with advanced or metastatic solid tumors, including breast cancer. Breast cancer is one of the most common cancers in women.

BG-75202 is an experimental drug that blocks proteins called KAT6A and 6B. These proteins are believed to help tumor growth in a number of cancers including certain types of breast cancer and other solid tumors. By blocking KAT6A and 6B, BG-75202 may be able to slow down or stop the growth of tumor cells.

This study consists of 2 parts, one called dose escalation and safety expansion and the other called dose optimization and dose expansion.

During the dose escalation and safety expansion part, the study doctors will test different doses of the study drug. This part of the study will evaluate BG-75202 alone (monotherapy) and combined with another drug (combination therapy).

During the dose optimization and dose expansion part, the study doctors will test the study drug in a larger number of people using the dose(s) identified from dose escalation and safety expansion. In this part of the study, BG-75202 will be taken with 1 or 2 other drugs.

The study will enroll participants with advanced or metastatic solid tumors at multiple centers worldwide.

The overall time to participate in this study may be up to approximately five years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, NSW 2148
        • Recruiting
        • Blacktown Cancer and Haematology Centre
      • Camperdown, New South Wales, Australia, NSW 2050
        • Recruiting
        • Chris Obrien Lifehouse
    • South Australia
      • Adelaide, South Australia, Australia, SA 5000
        • Recruiting
        • Cancer Research South Australia
    • Victoria
      • Heidelberg, Victoria, Australia, VIC 3084
        • Recruiting
        • Austin Health
      • Melbourne, Victoria, Australia, VIC 3000
        • Recruiting
        • Peter Maccallum Cancer Centre
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510555
        • Recruiting
        • Sun Yat Sen University Cancer Center Huangpu Branch
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Harbin Medical University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210036
        • Recruiting
        • Jiangsu Province Hospital Longjiang Branch
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Recruiting
        • Fudan University Shanghai Cancer Centerpudong
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo Di Oncologia
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori Fondazione G Pascale
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Rozzano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall Dhebron
      • Barcelona, Spain, 8023
        • Recruiting
        • Next Oncology Barcelona
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28240
        • Recruiting
        • Hospital Clinico San Carlos
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de La Victoria
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0004
        • Recruiting
        • University of Alabama At Birmingham Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Recruiting
        • Washington University in St Louis
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Next Oncology Austin
      • Houston, Texas, United States, 77030-4009
        • Recruiting
        • The University of Texas Md Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109-4433
        • Recruiting
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, Part 2A, 2B, and SE Parts 1A and 1B (except Food Effect): 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 1 line of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload) in the advanced/metastatic setting.
  • Food Effect only in SE Parts 1A or 1B: Patients with histologically or cytologically confirmed advanced, metastatic breast cancer who have exhausted, are intolerant of all available standard-of-care therapies, and/or without available standard-of-care therapies.
  • Parts 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Drug: BG-75202

Administered orally.
Experimental: Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist.
Drug: BG-75202

Administered orally.

Drug: Estrogen Receptor Antagonist

Administered by intramuscular injection.
Experimental: Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist

Participants will receive BG-75202 in combination with an estrogen receptor antagonist.
Drug: BG-75202

Administered orally.

Drug: Estrogen Receptor Antagonist

Administered by intramuscular injection.
Experimental: Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor

Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
Drug: BG-75202

Administered orally.

Drug: CDK4 Inhibitor

Administered orally.

Drug: Aromatase Inhibitor

Administered orally.
Experimental: Part 2B: Safety Lead-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor

Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor.
Drug: BG-75202

Administered orally.

Drug: CDK4 Inhibitor

Administered orally.

Drug: Aromatase Inhibitor

Administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1 and Part 2B (Safety Lead-in): 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.
From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months
Part 1 and Part 2B (Safety Lead-in): 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.
Estimated approximately 1 year
Part 2 A and Part 2C: 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).
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Parts 1 and 2: Terminal Half-Life (t1/2) of BG-75202
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Part 1 and Part 2B (Safety Lead-in): 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.
Up to approximately 1 year
Duration of Response (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.
Up to approximately 2 years
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.
Up to approximately 2 years
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).
Up to approximately 2 years
Part 2: Time to Response (TTR)
Time Frame: Up to approximately 2 years

TTR is defined as the time from treatment initiation to the first determination of objective response.
Up to approximately 2 years
Part 2A and Part 2C: 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.
Up to approximately 2 years
Part 2A and Part 2C: 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.
Up to approximately 2 years
Part 2A and Part 2C: Recommended Phase 2 Dose (RP2D) or Recommended Phase 3 Dose (RP3D)
Time Frame: Up to approximately 2 years

The RP2D or RP3D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeOne Medicines

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, BeOne Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BG-75202-101
  • 2025-523553-34-00 (Ctis)
  • 2025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings