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

RecruitingPhase 1

Sponsor: BeOne Medicines

Conditions: Advanced Solid Tumor

Interventions: BG-75098, BGB-43395, Fulvestrant

Countries: United States, Australia, China, Denmark

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (22)

Birmingham, Alabama, United States
New Haven, Connecticut, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Blacktown, New South Wales, Australia
St Leonards, New South Wales, Australia
Auchenflower, Queensland, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Beijing, Beijing Municipality, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Jinan, Shandong, China
Weifang, Shandong, China
Copenhagen, Denmark