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Breast CancerPhase 1NCT07222267

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

A Phase 1 study testing BG-75202, CDK4 Inhibitor and Estrogen Receptor Antagonist in people with Breast Cancer and Advanced Solid Tumor, run by BeOne Medicines at 32 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Advanced Solid Tumor
What is being tested?
BG-75202, CDK4 Inhibitor and Estrogen Receptor Antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
32 sitesin 6 countries
Study dates
11 Dec 2025to 13 Jan 2037
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

32 sites in 6 countries

China11 sites, 11 recruiting
  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting
  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting
  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting
  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting
  • Sun Yat Sen University Cancer Center Huangpu Branch

    Guangzhou, Guangdong, 510555

    Recruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Recruiting
  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting
  • Jiangsu Province Hospital Longjiang Branch

    Nanjing, Jiangsu, 210036

    Recruiting
  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality, 201321

    Recruiting
  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting
  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Recruiting

Other trials in China

United States6 sites, 6 recruiting
  • Next Oncology Austin

    Austin, Texas, 78758

    Recruiting
  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama, 35294-0004

    Recruiting
  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting
  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting
  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433

    Recruiting
  • Washington University in St Louis

    St Louis, Missouri, 63110-1010

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting
  • Cancer Research South Australia

    Adelaide, South Australia, SA 5000

    Recruiting
  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

    Recruiting
  • Chris Obrien Lifehouse

    Camperdown, New South Wales, NSW 2050

    Recruiting
  • Austin Health

    Heidelberg, Victoria, VIC 3084

    Recruiting
  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

    Recruiting

Other trials in Australia

Spain5 sites, 5 recruiting
  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

    Recruiting
  • Next Oncology Barcelona

    Barcelona, 8023

    Recruiting
  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting
  • Hospital Clinico San Carlos

    Madrid, 28240

    Recruiting
  • Hospital Universitario Virgen de La Victoria

    Málaga, 29010

    Recruiting

Other trials in Spain

Italy4 sites, 4 recruiting
  • Istituto Europeo Di Oncologia

    Milan, 20141

    Recruiting
  • Istituto Nazionale Tumori Fondazione G Pascale

    Naples, 80131

    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Recruiting
  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

New Zealand1 site, 1 recruiting
  • Auckland City Hospital

    Auckland, 1023

    Recruiting

Other trials in New Zealand

About this study

Official 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

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.

Being tested
BG-75202, CDK4 Inhibitor, Estrogen Receptor Antagonist, Aromatase Inhibitor
Keywords
KAT6 inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG-75202Drug

    Administered orally.

  • CDK4 InhibitorDrug

    Administered orally.

  • Estrogen Receptor AntagonistDrug

    Administered by intramuscular injection.

  • Aromatase InhibitorDrug

    Administered orally.

Study groups in NCT07222267
Study groupRoleWhat they receive
Part 1A: Dose Escalation and Safety Expansion, BG-75202 MonotherapyExperimentalSequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Receives: Drug: BG-75202
Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor AntagonistExperimentalSequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist.
Receives: Drug: BG-75202; Drug: Estrogen Receptor Antagonist
Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor AntagonistExperimentalParticipants will receive BG-75202 in combination with an estrogen receptor antagonist.
Receives: Drug: BG-75202; Drug: Estrogen Receptor Antagonist
Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase InhibitorExperimentalParticipants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor.
Receives: Drug: BG-75202; Drug: CDK4 Inhibitor; Drug: Aromatase Inhibitor
Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase InhibitorExperimentalParticipants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
Receives: Drug: BG-75202; Drug: CDK4 Inhibitor; Drug: Aromatase Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: 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.

    Measured: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months

  2. Part 1: Recommended Dose for Expansion (RDFE)

    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.

    Measured: Estimated approximately 1 year

  3. Part 2: Overall Response Rate (ORR)

    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).

    Measured: Up to approximately 2 years

Secondary outcomes (14)
  1. Part 1: ORR

    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.

    Measured: Up to approximately 1 year

  2. Part 1: Duration of Response (DOR)

    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.

    Measured: Up to approximately 1 year

  3. Part 1: Time to Response (TTR)

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

    Measured: Up to approximately 1 year

  4. Part 2: DOR

    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.

    Measured: Up to approximately 2 years

  5. Part 2: TTR

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

    Measured: Up to approximately 2 years

  6. Part 2: Disease Control Rate (DCR)

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

    Measured: Up to approximately 2 years

  7. Part 2: Clinical Benefit Rate (CBR)

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

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

  9. Part 2: 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, and laboratory values.

    Measured: Up to approximately 2 years

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

    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.

    Measured: Up to approximately 2 years

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

    Measured: Up to approximately 4 months

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

    Measured: Up to approximately 4 months

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

    Measured: Up to approximately 4 months

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

    Measured: Up to approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2025
  2. Study start11 Dec 2025
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion13 Jan 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07222267
Sponsor's protocol ID
BG-75202-101
Other IDs
2025-523553-34-00, 2025
Status last verified
Sep 2026
First submitted
28 Oct 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BG-75202, CDK4 Inhibitor and Estrogen Receptor Antagonist in people with Breast Cancer and Advanced Solid Tumor, run by BeOne Medicines at 32 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China, United States, Australia, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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