A Phase 1 interventional study of BG-75202 and CDK4 Inhibitor in Breast Cancer and Advanced Solid Tumor, sponsored by BeOne Medicines. Recruiting at 32 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment
Among 1,928 studies in Breast Neoplasms with a site in China — 866 open to participants now, 1,064 under way, 210 of them phase 3. Breast Neoplasms · China.
Among the 1,928 studies in Breast Neoplasms with a site in China, this one is the 620th largest by planned enrollment of the 1,519 interventional ones that give a count, is one of 237 that started in 2025, is one of 171 in phase 1, reaches primary completion later than 975 of the 1,063 other live ones, and was the 1,668th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →866 of the 1,928 studies in Breast Neoplasms with a site in China are open now. Recruiting first, the newest first:
First Affiliated Hospital of Guangxi Medical University · Sites in China
Ages 18–70 · Women only
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Fudan University · Sites in China
Ages 18–75 · Women only
Fudan University · Sites in China
Ages 18+ · Women only
Guangdong Provincial People's Hospital · Sites in China
Ages 18–75 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,928 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 279 · Phase 2 641 · Phase 3 371 · Phase 4 51
First in 1997; this study’s year is marked. 237 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 186 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 120 across the 1,519 interventional studies, 240 across the 407 observational. Of the 444 that completed or were terminated, 77 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
488 of 1,928 have an industry lead sponsor. The 10 most frequent:
BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
BeOne Medicines has 8 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
251 of the studies in Breast Neoplasms with a site in China that are under way reach primary completion within a year, 43 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT06954961Phase 3InventisBio Co., LtdA Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer | 2026-11-30 |
| NCT06968585Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy | 2026-11-30 |
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
Add all 251 to your calendar (.ics) → With an account.
Among the 1,928 studies in Breast Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
The criteria were revised on the registry on Nov 12, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Drug: BG-75202
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist.
Drug: BG-75202 · Drug: Estrogen Receptor Antagonist
Participants will receive BG-75202 in combination with an estrogen receptor antagonist.
Drug: BG-75202 · Drug: Estrogen Receptor Antagonist
Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor.
Drug: BG-75202 · Drug: CDK4 Inhibitor · Drug: Aromatase Inhibitor
Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
Drug: BG-75202 · Drug: CDK4 Inhibitor · Drug: Aromatase Inhibitor
Administered orally.
Administered orally.
Administered by intramuscular injection.
Administered orally.
Part 1 and Part 2B (Safety Lead-in): 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.
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
Part 1 and Part 2B (Safety Lead-in): 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.
Time frame: Estimated approximately 1 year
Part 2 A and Part 2C: 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).
Time frame: Up to approximately 2 years
Part 1 and Part 2B (Safety Lead-in): 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.
Time frame: Up to approximately 1 year
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.
Time frame: Up to approximately 2 years
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.
Time frame: Up to approximately 2 years
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks).
Time frame: Up to approximately 2 years
Part 2: Time to Response (TTR)
TTR is defined as the time from treatment initiation to the first determination of objective response.
Time frame: Up to approximately 2 years
Part 2A and Part 2C: 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.
Time frame: Up to approximately 2 years
Part 2A and Part 2C: 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.
Time frame: Up to approximately 2 years
Part 2A and Part 2C: Recommended Phase 2 Dose (RP2D) or Recommended Phase 3 Dose (RP3D)
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.
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
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Sep 2029, 45 months after the start.
Of 389 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 45 months is above that.
Counting every sponsor, half of 761 studies reached it within 44 months; a quarter within 25 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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