NCT07226349 · BeOne Medicines
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
What this study is about
The purpose of this study is to evaluate safety, tolerability, how the drug moves through the body (PK), how the drug affects the body, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.
View original scientific description
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.
Interventions
DRUG
BG-75098
Administered orally.
DRUG
BGB-43395
Administered orally.
DRUG
Fulvestrant
Administered by intramuscular injection.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Birmingham, Alabama
- New Haven, Connecticut
- Baltimore, Maryland
- Boston, Massachusetts
- Houston, Texas
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations