Advanced Solid TumorPhase 1NCT07226349
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
A Phase 1 study testing BG-75098, BGB-43395 and Fulvestrant in people with Advanced Solid Tumor, run by BeOne Medicines at 23 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BG-75098, BGB-43395 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 11 Dec 2025to 1 Nov 2028
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 4 countries
United States8 sites, 8 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, 21287
- Recruiting
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010-3012
- Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
- Recruiting
Next Oncology Houston
Houston, Texas, 77054
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
China8 sites, 8 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
- Recruiting
Jiangsu Province Hospital Longjiang Branch
Nanjing, Jiangsu, 210036
- Recruiting
Weifang Peoples Hospital
Weifang, Shandong, 261000
- Recruiting
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
Wuhan, Hubei, 430048
Australia6 sites, 6 recruiting
- Recruiting
Icon Cancer Centre Wesley
Auchenflower, Queensland, QLD 4066
- Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
- Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144
- Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000
- Recruiting
One Clinical Research
Nedlands, Western Australia, WA 6009
- Recruiting
Genesiscare St Leonards
St Leonards, New South Wales, NSW 2065
About this study
Official 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
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.
Read the detailed description
This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
- Conditions
- Advanced Solid Tumor
- Being tested
- BG-75098, BGB-43395, Fulvestrant
- Keywords
- Cyclin-Dependent Kinase 2- Targeted Protein Degrader, CDK2, CDK4, CDK4 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-75098Drug
Administered orally.
BGB-43395Drug
Administered orally.
FulvestrantDrug
Administered by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy | Experimental | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy. Receives: Drug: BG-75098 |
| Phase 1a, Part B: Dose Escalation, BG-75098 Combination | Experimental | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant. Receives: Drug: BG-75098; Drug: BGB-43395; Drug: Fulvestrant |
| Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination | Experimental | Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant. Receives: Drug: BG-75098; Drug: BGB-43395; Drug: Fulvestrant |
| Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy | Experimental | Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a. Receives: Drug: BG-75098 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: 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, up to approximately 12 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098
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.
Measured: Up to approximately 2 years
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and Fulvestrant
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.
Measured: Up to approximately 2 years
Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator
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.
Measured: Up to approximately 2 years
Secondary outcomes (20)
Phase 1a: ORR as Assessed by the Investigator
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.
Measured: Up to approximately 2 years
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
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.
Measured: Up to approximately 2 years
Phase 1a: Time to Response (TTR) as Assessed by the Investigator
TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1.
Measured: Up to approximately 2 years
Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator
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.
Measured: Up to approximately 2 years
Phase 1b: DOR as Assessed by the Investigator
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.
Measured: Up to approximately 2 years
Phase 1b: TTR as Assessed by the Investigator
TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1.
Measured: Up to approximately 2 years
Phase 1b: Disease Control Rate (DCR)
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.
Measured: Up to approximately 2 years
Phase 1b: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.
Measured: Up to approximately 2 years
Phase 1b: PFS
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.
Measured: Up to approximately 2 years
Phase 1b: Number of Participants with AEs
Number of participants with TEAEs and SAEs, including physical examination findings, electrocardiogram results, and laboratory values.
Measured: Up to approximately 2 years
Observed Plasma Maximum Concentration (Cmax) of BG-75098
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Observed Plasma Trough Concentration (Ctrough) of BG-75098
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Area Under the Concentration-Time Curve (AUC) of BG-75098
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Terminal Half-Life (t1/2) of BG-75098
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Phase 1b: Plasma Concentrations of BG-75098
Measured: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)
Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Phase 1a: Area Under the Concentration-Time Curve (AUC) of BGB-43395
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Phase 1a: Terminal Half-Life (t1/2) of BGB-43395
Measured: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)
Plasma Concentrations of BGB-43395
Measured: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start11 Dec 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 105 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
- NCT07226349
- Sponsor's protocol ID
- BG-75098-101
- Other IDs
- 2025-523165-19-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 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, 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
- ClinicalTrials.gov ID
- NCT07226349
- Acronym / sponsor ID
- BG-75098-101
- Conditions
- Advanced Solid Tumor
- Keywords
- Cyclin-Dependent Kinase 2- Targeted Protein Degrader, CDK2, CDK4, CDK4 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 10 Nov 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 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.
Detailed description
This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy | Experimental | Drug: BG-75098Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy. |
| Phase 1a, Part B: Dose Escalation, BG-75098 Combination | Experimental | Drug: BG-75098, Drug: BGB-43395, Drug: FulvestrantSequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant. |
| Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination | Experimental | Drug: BG-75098, Drug: BGB-43395, Drug: FulvestrantParticipants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant. |
| Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy | Experimental | Drug: BG-75098Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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-75098Administered orally. | Drug | Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy, Phase 1a, Part B: Dose Escalation, BG-75098 Combination, Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination, Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy |
| BGB-43395Administered orally. | Drug | Phase 1a, Part B: Dose Escalation, BG-75098 Combination, Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination |
| FulvestrantAdministered by intramuscular injection. | Drug | Phase 1a, Part B: Dose Escalation, BG-75098 Combination, Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination |
Primary outcome
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.
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.
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.
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.
20 secondary outcomes
Phase 1a: ORR as Assessed by the Investigator
Time frame: Up to approximately 2 years
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to approximately 2 years
Phase 1a: Time to Response (TTR) as Assessed by the Investigator
Time frame: Up to approximately 2 years
Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator
Time frame: Up to approximately 2 years
Phase 1b: DOR as Assessed by the Investigator
Time frame: Up to approximately 2 years
Phase 1b: TTR as Assessed by the Investigator
Time frame: Up to approximately 2 years
Phase 1b: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Phase 1b: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 2 years
Phase 1b: PFS
Time frame: Up to approximately 2 years
Phase 1b: Number of Participants with AEs
Time frame: Up to approximately 2 years
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)
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)
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)
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)
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)
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)
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)
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)
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)
Plasma Concentrations of BGB-43395
Time frame: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)
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
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG-75098, BGB-43395 and Fulvestrant in people with Advanced Solid Tumor, run by BeOne Medicines at 23 sites in 4 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 7 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 23 sites in United States, China, Australia, Denmark. 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 (8778285568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 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.