Clinical trial NCT06997029: A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
Official title: A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Advanced Breast Cancer
Advanced Ovarian Cancer
Keywords: cancer
oncology
solid tumor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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.
* For Part 2A only, participants must have CCNE1-amplified ovarian cancer

Exclusion Criteria:

* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Up to Day 28 From Last Dose
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 28 From Last Dose
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to Day 28 From Last Dose
measure: Number of Participants With AEs Leading to Discontinuation
timeFrame: Up to Day 28 From Last Dose
measure: Number of Participants With TEAEs Leading to Death
timeFrame: Up to Day 28 From Last Dose
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of BMS-986500
timeFrame: Up to Approximately 3 Months
measure: Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500
timeFrame: Up to Approximately 3 Months
measure: Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500
timeFrame: Up to Approximately 3 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0001
state: Alabama
city: Fullerton
country: United States
facility: Local Institution - 0003
state: California
city: Greenbrae
country: United States
facility: Local Institution - 0013
state: California
city: La Jolla
country: United States
facility: Local Institution - 0009
state: California
city: Newport Beach
country: United States
facility: Local Institution - 0010
state: California
city: Aurora
country: United States
facility: Local Institution - 0008
state: Colorado
city: Boston
country: United States
facility: Local Institution - 0006
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution - 0004
state: Missouri
city: Lebanon
country: United States
facility: Local Institution - 0002
state: New Hampshire
city: Buffalo
country: United States
facility: Local Institution - 0014
state: New York
city: New York
country: United States
facility: Local Institution - 0011
state: New York
city: New York
country: United States
facility: Local Institution - 0012
state: New York
city: San Antonio
country: United States
facility: Local Institution - 0007
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: