A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
NCT ID: NCT07226349
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
105 participants
INTERVENTIONAL
2025-12-02
2029-03-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy
Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy.
BG-75098
Administered orally.
Phase 1a, Part B: Dose Escalation, BG-75098 Combination
Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant.
BG-75098
Administered orally.
BGB-43395
Administered orally.
Fulvestrant
Administered by intramuscular injection.
Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination
Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant.
BG-75098
Administered orally.
BGB-43395
Administered orally.
Fulvestrant
Administered by intramuscular injection.
Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy
Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a.
BG-75098
Administered orally.
Interventions
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BG-75098
Administered orally.
BGB-43395
Administered orally.
Fulvestrant
Administered by intramuscular injection.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Next Houston
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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2025-523165-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
BG-75098-101
Identifier Type: -
Identifier Source: org_study_id