A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be ≥ 18 years of age.
Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Disqualifiers
Participants must not have an active brain metastasis.
Participants must not have impaired cardiac function or clinically significant cardiac disease.
Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
Participants must not have Grade ≥ 2 peripheral neuropathy.
Trial design
Design model
Parallel
Treatments tested in this trial
BMS-986500
DrugSpecified dose of specified days
Palbociclib
DrugSpecified dose on specified days
Fulvestrant
DrugSpecified dose on specified days
Treatment groups
234 Participants
are divided into 5 treatment groupsGroup A: Part 1A Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part 1B Combination Dose EscalationExperimental treatment 3 interventions
Group C: Part 1C Monotherapy Pharmacodynamic (PD) Sub-studyExperimental treatment 1 intervention
Group D: Part 2A Monotherapy Dose ExpansionExperimental treatment 1 intervention
Group E: Part 2B Combination Dose ExpansionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame
Up to Day 28 From Last Dose2
Number of Participants With Adverse Events (AEs)
Time frame
Up to Day 28 From Last Dose3
Number of Participants With Serious Adverse Events (SAEs)
Time frame
Up to Day 28 From Last Dose4
Number of Participants With AEs Leading to Discontinuation
Time frame
Up to Day 28 From Last DoseSecondary outcomes
1
Maximum Observed Serum Concentration (Cmax) of BMS-986500
Time frame
Up to Approximately 2 Years2
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500
Time frame
Up to Approximately 2 Years3
Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500
Time frame
Up to Approximately 2 YearsSponsors and contacts
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Source ClinicalTrials.gov