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
Qualifiers
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
Treatments tested in this trial
- BMS-986500
- Palbociclib
- Fulvestrant
Treatment groups
234 Participants
are divided into 5 treatment groupsLocations
21Denmark
Odense Universitetshospital5000, OdenseRegion Syddanmark, Denmark
Copenhagen University Hospital2100, Copenhagen Denmark
Japan
National Cancer Center Hospital East277-8577, KashiwaChiba, Japan
Kansai Medical University Hospital573-1191, HirakataOsaka, Japan
Sponsors and collaborators
Bristol-Myers Squibb
Lead sponsor
Source ClinicalTrials.gov