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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
- 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
United States6 sites, 6 recruiting
- 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
Australia5 sites, 5 recruiting
- 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
Spain5 sites, 5 recruiting
- 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
Italy4 sites, 4 recruiting
- 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
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
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.
- Conditions
- Breast Cancer, Advanced Solid Tumor
- 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 group | Role | What they receive |
|---|---|---|
| Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy | Experimental | Sequential 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 Antagonist | Experimental | Sequential 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 Antagonist | Experimental | Participants 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 Inhibitor | Experimental | Participants 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 Inhibitor | Experimental | Participants 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.
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
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
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)
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
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
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
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
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
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
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
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
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
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
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202
Measured: Up to approximately 4 months
Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Measured: Up to approximately 4 months
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202
Measured: Up to approximately 4 months
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.
- First posted29 Oct 2025
- Study start11 Dec 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion13 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07222267
- Acronym / sponsor ID
- BG-75202-101
- Conditions
- Breast Cancer, Advanced Solid Tumor
- Keywords
- KAT6 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 13 Jan 2037 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy | Experimental | Drug: BG-75202Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
| Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist | Experimental | Drug: BG-75202, Drug: Estrogen Receptor AntagonistSequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. |
| Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist | Experimental | Drug: BG-75202, Drug: Estrogen Receptor AntagonistParticipants will receive BG-75202 in combination with an estrogen receptor antagonist. |
| Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor | Experimental | Drug: BG-75202, Drug: CDK4 Inhibitor, Drug: Aromatase InhibitorParticipants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. |
| Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor | Experimental | Drug: BG-75202, Drug: CDK4 Inhibitor, Drug: Aromatase InhibitorParticipants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG-75202Administered orally. | Drug | Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy, Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist, Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist, Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor, Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor |
| CDK4 InhibitorAdministered orally. | Drug | Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor, Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor |
| Estrogen Receptor AntagonistAdministered by intramuscular injection. | Drug | Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist, Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist |
| Aromatase InhibitorAdministered orally. | Drug | Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor, Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor |
Primary outcome
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.
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.
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).
14 secondary outcomes
Part 1: ORR
Time frame: Up to approximately 1 year
Part 1: Duration of Response (DOR)
Time frame: Up to approximately 1 year
Part 1: Time to Response (TTR)
Time frame: Up to approximately 1 year
Part 2: DOR
Time frame: Up to approximately 2 years
Part 2: TTR
Time frame: Up to approximately 2 years
Part 2: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Part 2: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 2 years
Part 2: Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Part 2: Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Part 2: Recommended Phase 2 Dose (RP2D)
Time frame: Up to approximately 2 years
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202
Time frame: Up to approximately 4 months
Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Time frame: 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
Parts 1 and 2: Terminal Half-Life (t1/2) of BG-75202
Time frame: Up to approximately 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
32 sites in 6 countries: see every site and its status.
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.