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RecruitingInterventionalPhase 1

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

NCT ID: NCT07226349Sponsor: BeOne MedicinesLast updated: 2026-06-03

Summary

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.

Arms & interventions

  • DrugBG-75098

    Administered orally.

  • DrugBGB-43395

    Administered orally.

  • DrugFulvestrant

    Administered by intramuscular injection.

Outcome measures

Primary

  • Phase 1a: Number of Participants with Adverse Events (AEs)

    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.

    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

    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.

    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

    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.

    Time frame: Up to approximately 2 years

  • Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator

    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.

    Time frame: Up to approximately 2 years

Secondary

  • 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)

  • Area Under the Concentration-Time Curve (AUC) of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  • Terminal Half-Life (t1/2) of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  • Phase 1b: Plasma Concentrations of BG-75098

    Time frame: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)

  • Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  • Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  • Phase 1a: Area Under the Concentration-Time Curve (AUC) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  • Phase 1a: Terminal Half-Life (t1/2) of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)

  • Plasma Concentrations of BGB-43395

    Time frame: Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (6)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, 35294-0004

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06510

Recruiting

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland, 21287

Recruiting

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009

Recruiting

Next Houston

Houston, Texas, 77054

Recruiting

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-1222

Recruiting