Solid TumoursPhase 1/2NCT07160725
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
A Phase 1/2 study testing BMS-986517 and Pumitamig in people with Solid Tumours, run by Bristol-Myers Squibb at 20 sites in 5 countries.
Trial summary
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- BMS-986517 and Pumitamig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 15 Oct 2025to 1 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 have an ECOG performance status of 0 to 1.
- Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
- Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
Who cannot join
- Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
- Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
- Participants must not have history of serious recurrent infections.
- Participants must not have impaired cardiac function or history of severe heart disease.
- For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
- For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
- For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
20 sites in 5 countries
United States9 sites, 9 recruiting
- Recruiting
START - Dallas Fort Worth
Fort Worth, Texas, 76104
Henry Xiong, Site 0030, 682-350-3010
- Not yet recruiting
Local Institution - 0033
Irvine, California, 92612
Site 0033
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Anthony El-Khoueiry, Site 0002, 323-865-3967
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868-3201
Rupali Nabar, Site 0021, 310-222-2222
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Dan Zandberg, Site 0008, 412-864-7955
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Drew Rasco, Site 0020, 210-593-5250, hopeteam@startresearch.com
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Lauren Shih, Site 0028, 206-606-7763
- Recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Steven Powell, Site 0005, 605-328-8000
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
William McKean, Site 0031, 801-907-4750
Spain6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0022
Badalona, Barcelona [Barcelona], 08916
Site 0022
- Not yet recruiting
Local Institution - 0024
Barcelona, Barcelona [Barcelona], 08035
Site 0024
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Victor Moreno Garcia, Site 0027, 915504800ext2805
- Not yet recruiting
Local Institution - 0023
Madrid, 28050
Site 0023
- Not yet recruiting
Local Institution - 0026
Málaga, Andalusia, 29010
Site 0026
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Ignacio Melero Bermejo, Site 0025, 34948255400
Denmark3 sites, 3 recruiting
- Recruiting
Herlev and Gentofte Hospital
Copenhagen, Capital Region, 2730
Mogens Boisen, Site 0016, +45 38 68 91 25
- Recruiting
Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Kristoffer Rohrberg, Site 0017, + 45 3545 9540
- Recruiting
Odense Universitetshospital
Odense, Region Syddanmark, 5000
Annette Kodahl, Site 0015, +45 21133379
China1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0034
Guangzhou, Guangdong, 510120
Site 0034
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Noboru Yamamoto, Site 0029, 81335422511
About this study
Official title: A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors
- Conditions
- Solid Tumours
- Being tested
- BMS-986517, Pumitamig
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986517Drug
Specified dose on specified days
PumitamigDrug
Also called BMS-986545, BNT327, PMS002
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: BMS-986517 |
| Part 1B Combination Dose Escalation | Experimental | Not described Receives: Drug: BMS-986517; Drug: Pumitamig |
| Part 1C: Monotherapy PD Sub-study | Experimental | Not described Receives: Drug: BMS-986517 |
| Part 2A: Monotherapy Dose Expansion Cohort A | Experimental | Not described Receives: Drug: BMS-986517 |
| Part 2A: Monotherapy Dose Expansion Cohort B | Experimental | Not described Receives: Drug: BMS-986517 |
| Part 2A: Monotherapy Dose Expansion Cohort C | Experimental | Not described Receives: Drug: BMS-986517 |
| Part 2B: Combination Dose Expansion Cohort A | Experimental | Not described Receives: Drug: BMS-986517; Drug: Pumitamig |
| Part 2B: Combination Dose Expansion Cohort B | Experimental | Not described Receives: Drug: BMS-986517; Drug: Pumitamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AE)
Measured: Up to approximately 2 years
Number of Participants with Serious Adverse Events (SAE)
Measured: Up to approximately 2 years
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria
For part 1 only
Measured: Up to Day 21
Number of Participants with AEs Leading to Discontinuation
Measured: Up to approximately 2 years
Number of Participants with AEs Leading to Deaths
Measured: Up to approximately 2 years
Secondary outcomes (6)
Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment
Measured: Up to approximately 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment
Measured: Up to approximately 3 years
Maximum Plasma Concentration (Cmax)
Measured: Up to approximately 2 years
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: Up to approximately 2 years
Area Under Curve (AUC)
Measured: Up to approximately 2 years
Total anti-drug antibodies (ADAs)
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 posted8 Sep 2025
- Study start15 Oct 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 540 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
- NCT07160725
- Sponsor's protocol ID
- CA254-0001
- Other IDs
- EU CTR, WHO
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2025
- Last updated
- 11 Aug 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07160725
- Acronym / sponsor ID
- CA254-0001
- Conditions
- Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1A Monotherapy Dose Escalation | Experimental | Drug: BMS-986517 |
| Part 1B Combination Dose Escalation | Experimental | Drug: BMS-986517, Drug: Pumitamig |
| Part 1C: Monotherapy PD Sub-study | Experimental | Drug: BMS-986517 |
| Part 2A: Monotherapy Dose Expansion Cohort A | Experimental | Drug: BMS-986517 |
| Part 2A: Monotherapy Dose Expansion Cohort B | Experimental | Drug: BMS-986517 |
| Part 2A: Monotherapy Dose Expansion Cohort C | Experimental | Drug: BMS-986517 |
| Part 2B: Combination Dose Expansion Cohort A | Experimental | Drug: BMS-986517, Drug: Pumitamig |
| Part 2B: Combination Dose Expansion Cohort B | Experimental | Drug: BMS-986517, Drug: Pumitamig |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have an ECOG performance status of 0 to 1.
- Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
- Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
Key exclusion criteria (8 listed)
- Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
- Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
- Participants must not have history of serious recurrent infections.
- Participants must not have impaired cardiac function or history of severe heart disease.
- For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986517Specified dose on specified days | Drug | Part 1A Monotherapy Dose Escalation, Part 1B Combination Dose Escalation, Part 1C: Monotherapy PD Sub-study, Part 2A: Monotherapy Dose Expansion Cohort A, Part 2A: Monotherapy Dose Expansion Cohort B, Part 2A: Monotherapy Dose Expansion Cohort C, Part 2B: Combination Dose Expansion Cohort A, Part 2B: Combination Dose Expansion Cohort B |
| PumitamigAlso: BMS-986545, BNT327, PMS002Specified dose on specified days | Drug | Part 1B Combination Dose Escalation, Part 2B: Combination Dose Expansion Cohort A, Part 2B: Combination Dose Expansion Cohort B |
Primary outcome
Number of Participants with Adverse Events (AE)
Time frame: Up to approximately 2 years
Number of Participants with Serious Adverse Events (SAE)
Time frame: Up to approximately 2 years
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria
Time frame: Up to Day 21
For part 1 only
Number of Participants with AEs Leading to Discontinuation
Time frame: Up to approximately 2 years
Number of Participants with AEs Leading to Deaths
Time frame: Up to approximately 2 years
6 secondary outcomes
Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment
Time frame: Up to approximately 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment
Time frame: Up to approximately 3 years
Maximum Plasma Concentration (Cmax)
Time frame: Up to approximately 2 years
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Up to approximately 2 years
Area Under Curve (AUC)
Time frame: Up to approximately 2 years
Total anti-drug antibodies (ADAs)
Time frame: Up to approximately 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
Related trials for Solid Tumours
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor
RecruitingPhase 2
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
MSI-H/dMMR Solid Tumors
RecruitingObservational study
Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Malignant Solid Tumors, Other Neoplasms Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986517 and Pumitamig in people with Solid Tumours, run by Bristol-Myers Squibb at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, Denmark, China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE) (time frame: Up to approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.