Menu
Recruiting NCT07226349

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

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BG-75098, BGB-43395, Fulvestrant.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

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.

Detailed description

This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

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]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098 [Time frame: Up to approximately 2 years]
  • 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]
  • Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator [Time frame: Up to approximately 2 years]
Secondary outcome measures (12)
  • Phase 1a: ORR as Assessed by the Investigator [Time frame: Up to approximately 2 years]
  • Phase 1a: Duration of Response (DOR) as Assessed by the Investigator [Time frame: Up to approximately 2 years]
  • Phase 1a: Time to Response (TTR) as Assessed by the Investigator [Time frame: Up to approximately 2 years]
  • Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator [Time frame: Up to approximately 2 years]
  • Phase 1b: DOR as Assessed by the Investigator [Time frame: Up to approximately 2 years]
  • Phase 1b: TTR as Assessed by the Investigator [Time frame: Up to approximately 2 years]
  • Phase 1b: Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
  • Phase 1b: Clinical Benefit Rate (CBR) [Time frame: Up to approximately 2 years]
  • Phase 1b: PFS [Time frame: Up to approximately 2 years]
  • Phase 1b: Number of Participants with AEs [Time frame: Up to approximately 2 years]
  • Observed Plasma Maximum Concentration (Cmax) of BG-75098 [Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)]
  • Observed Plasma Trough Concentration (Ctrough) of BG-75098 [Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 8 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou
  • Harbin Medical University Cancer Hospital — Harbin
  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan
  • Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinh — Wuhan
  • Jiangsu Province Hospital Longjiang Branch — Nanjing
  • Qilu Hospital of Shandong University — Jinan
  • Weifang Peoples Hospital — Weifang
United States · 6 centers
  • University of Alabama At Birmingham Hospital — Birmingham
  • Yale Cancer Center — New Haven
  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore
  • The University of Texas Md Anderson Cancer Center — Houston
  • Next Houston — Houston
  • Medical College of Wisconsin — Milwaukee
Australia · 6 centers
  • Blacktown Cancer and Haematology Centre — Blacktown
  • Genesiscare St Leonards — St Leonards
  • Icon Cancer Centre Wesley — Auchenflower
  • Cabrini Hospital Malvern — Malvern
  • Peter Maccallum Cancer Centre — Melbourne
  • One Clinical Research — Nedlands
Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07226349 · BG-75098-101 · 2025-523165-19-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗