A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
BG-75098
DrugAdministered orally.
BGB-43395
DrugAdministered orally.
Fulvestrant
DrugAdministered by intramuscular injection.
Treatment groups
105 Participants
are divided into 4 treatment groupsGroup A: Phase 1a, Part A: Dose Escalation, BG-75098 MonotherapyExperimental treatment 1 intervention
Group B: Phase 1a, Part B: Dose Escalation, BG-75098 CombinationExperimental treatment 3 interventions
Group C: Phase 1b, Cohort 1: Dose Expansion, BG-75098 CombinationExperimental treatment 3 interventions
Group D: Phase 1b, Cohort 2: Dose Expansion, BG-75098 MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 years3
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 years4
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 yearsSecondary outcomes
1
Phase 1a: ORR as Assessed by the Investigator
ORR is defined as the percentage of participants with best overall response of CR or PR, as assessed by the investigator using RECIST v1.1.
Time frame
Up to approximately 2 years2
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
DOR is defined as the time from the first confirmed objective response assessed by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.
Time frame
Up to approximately 2 years3
Phase 1a: Time to Response (TTR) as Assessed by the Investigator
TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1.
Time frame
Up to approximately 2 years4
Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator
PFS is defined as the time from the date of the first dose of study treatment to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov