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Recruiting Phase 1 NCT07226349

A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumor

Sponsor: BeOne Medicines

trial.available_in: БГ
Overview
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.
Description
This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
Who can participate
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.
Locations 4
Australia (1)
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
China (1)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing , Beijing Municipality
Denmark (1)
Rigshospitalet
Copenhagen
United States (1)
University of Alabama At Birmingham Hospital
Birmingham , Alabama
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
11.12.2025
Completion date
01.11.2028
Registry ID
NCT07226349
Source
anzctr
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