Advanced Solid TumorPhase 1NCT06997029
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
A Phase 1 study testing BMS-986500, Palbociclib and Fulvestrant in people with Advanced Solid Tumor and Advanced Breast Cancer, run by Bristol-Myers Squibb at 21 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer
- What is being tested?
- BMS-986500, Palbociclib and Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 1 Aug 2025to 14 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
21 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com contact
First line of the email MUST contain NCT # and Site #. contact
21 sites in 3 countries
United States15 sites, 14 recruiting
- Not yet recruiting
Local Institution - 0008
Aurora, Colorado, 80045
Site 0008
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Mehmet Akce, Site 0001, 205-975-0832
- Completed
Local Institution - 0006
Boston, Massachusetts, 02215
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Christos Fountzilas, Site 0014, 716-845-4720
- Recruiting
START Dallas Fort Worth
Fort Worth, Texas, 76104
Henry Xiong, Site 0018, 682-350-3010
- Recruiting
Providence St. Jude Medical Center
Fullerton, California, 92835
Yung Lyou, Site 0003, 714-446-5900
- Recruiting
Marin Cancer Care
Greenbrae, California, 94904
Cyrus Mazidi, Site 0013, 415-925-5000
- Recruiting
Moores Cancer Center
La Jolla, California, 92093
Peter Vu, Site 0009, 858-822-2463
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Lionel Lewis, Site 0002, 603-381-1953
- Recruiting
Northwell Health-Cancer Institute
New Hyde Park, New York, 11042
Geraldine O'Sullivan Coyne, Site 0016
- Not yet recruiting
Local Institution - 0011
New York, New York, 10016
Site 0011
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ezra Rosen, Site 0012, 000-000-0000
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Monica Mita, Site 0010, 949-764-4060
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
David Sommerhalder, Site 0007, 210-580-9500
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Faisal Fa'ak, Site 0004
Japan4 sites, 4 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Takafumi Koyama, Site 0022, 81335422511
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Toshio Shimizu, Site 0020, +81728040101
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Chikako Funasaka, Site 0021, 81471331111
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Shigehisa Kitano, Site 0023, 0335200111
Denmark2 sites, 2 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen, 2100
Martin Højgaard, Site 0025, 4535456861
- Recruiting
Odense Universitetshospital
Odense, Region Syddanmark, 5000
Annette Kodahl, Site 0024, 004566113333
About this study
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
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.
- Being tested
- BMS-986500, Palbociclib, Fulvestrant
- Keywords
- cancer, oncology, solid tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986500Drug
Specified dose of specified days
PalbociclibDrug
Also called IBRANCE®, PD 0332991
Specified dose on specified days
FulvestrantDrug
Also called FASLODEX®
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: BMS-986500 |
| Part 1B Combination Dose Escalation | Experimental | Not described Receives: Drug: BMS-986500; Drug: Palbociclib; Drug: Fulvestrant |
| Part 1C Monotherapy Pharmacodynamic (PD) Sub-study | Experimental | Not described Receives: Drug: BMS-986500 |
| Part 2A Monotherapy Dose Expansion | Experimental | Not described Receives: Drug: BMS-986500 |
| Part 2B Combination Dose Expansion | Experimental | Not described Receives: Drug: BMS-986500; Drug: Palbociclib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Up to Day 28 From Last Dose
Number of Participants With Adverse Events (AEs)
Measured: Up to Day 28 From Last Dose
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to Day 28 From Last Dose
Number of Participants With AEs Leading to Discontinuation
Measured: Up to Day 28 From Last Dose
Number of Participants With TEAEs Leading to Death
Measured: Up to Day 28 From Last Dose
Secondary outcomes (3)
Maximum Observed Serum Concentration (Cmax) of BMS-986500
Measured: Up to Approximately 2 Years
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500
Measured: Up to Approximately 2 Years
Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500
Measured: Up to Approximately 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Aug 2025
- Primary completion14 Dec 2028 (estimated)
- Study completion14 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997029
- Sponsor's protocol ID
- CA243-0001
- Other IDs
- 2025-524334-26-00, U1111-1330-3304, 2025
- Status last verified
- Oct 2026
- First submitted
- 21 May 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html