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Recruiting NCT06997029

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor Advanced Breast Cancer Advanced Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986500, Palbociclib, Fulvestrant.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Denmark, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug BMS-986500
    Specified dose of specified days
  • Drug Palbociclib
    Specified dose on specified days
  • Drug Fulvestrant
    Specified dose on specified days

Primary outcome measures

  • Number of Participants With Dose Limiting Toxicities (DLTs) [Time frame: Up to Day 28 From Last Dose]
  • Number of Participants With Adverse Events (AEs) [Time frame: Up to Day 28 From Last Dose]
  • Number of Participants With Serious Adverse Events (SAEs) [Time frame: Up to Day 28 From Last Dose]
  • Number of Participants With AEs Leading to Discontinuation [Time frame: Up to Day 28 From Last Dose]
  • Number of Participants With TEAEs Leading to Death [Time frame: Up to Day 28 From Last Dose]
Secondary outcome measures (3)
  • Maximum Observed Serum Concentration (Cmax) of BMS-986500 [Time frame: Up to Approximately 2 Years]
  • Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500 [Time frame: Up to Approximately 2 Years]
  • Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500 [Time frame: Up to Approximately 2 Years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 15 centers
  • University of Alabama at Birmingham — Birmingham
  • Providence St. Jude Medical Center — Fullerton
  • Marin Cancer Care — Greenbrae
  • Moores Cancer Center — La Jolla
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Local Institution - 0008 — Aurora
  • Dana-Farber Cancer Institute — Boston
  • Washington University School of Medicine — St Louis
  • … and 7 more centers
Japan · 4 centers
  • National Cancer Center Hospital East — Kashiwa
  • Kansai Medical University Hospital — Hirakata
  • National Cancer Center Hospital — Chuo-ku
  • The Cancer Institute Hospital of JFCR — Koto-ku
Denmark · 2 centers
  • Odense Universitetshospital — Odense
  • Copenhagen University Hospital — Copenhagen

Identifiers

NCT: NCT06997029 · CA243-0001 · 2025-524334-26-00 · U1111-1330-3304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗