Advanced Solid TumorsPhase 1/2NCT06697197
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/2 study testing BMS-986482 and Pumitamig in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 21 sites in 9 countries.
Trial summary
The purpose of this study is to investigate the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-986482 and Pumitamig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 21 sitesin 9 countries
- Study dates
- 17 Feb 2025to 5 Jan 2029
- Phase
- Phase 1/2
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
- All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
Who cannot join
- History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
- Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- For participants in Part 1B1, 1B2, 2B1 and 2B2: active autoimmune disease or requirement for systemic immunosuppressive therapy.
- For participants in Part 1B1, 1B2, 2B1 and 2B2: History of interstitial lung disease or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
- For participants in Part 1B1, 1B2, 2B1 and 2B2: 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
21 sites in 9 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
21 sites in 9 countries
United States7 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0008
Aurora, Colorado, 80045
Site 0008
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Asim Amin, Site 0011, 980-442-2000
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Martin Gutierrez, Site 0009, 551-996-5863
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Irvine, California, 92612
Warren Chow, Site 0005, 626-372-7121
- Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Nagashree Seetharamu, Site 0007, 917-574-8494
- Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
Omid Hamid, Site 0030, 310-231-2121
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Cristina Rodriguez, Site 0010, 206-288-6748
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Elena Garralda Cabanas, Site 0033, 349327460004910
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Emiliano Calvo, Site 0034, +34934894304
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Ignacio Melero Bermejo, Site 0035, 34948255400
France2 sites, 2 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, Bouches-du-Rhône, 13385
Caroline Gaudy, Site 0016, +33491380000
- Recruiting
Gustave Roussy
Villejuif, Paris, 94800
Anna PATRIKIDOU, Site 0012, +3314214211
Greece2 sites, 2 recruiting
- Recruiting
General Hospital of Athens "Laiko"
Athens, Attikí, 11527
Dimitrios Ziogas, Site 0038, 306936490499
- Recruiting
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29
Georgios Lazaridis, Site 0039, 302313323959
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Massimo Di Nicola, Site 0037, 0223902506
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Matteo Simonelli, Site 0036, +390282244559
Netherlands2 sites, 2 recruiting
- Recruiting
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
Amsterdam, North Holland, 1066 CX
Tim Schutte, Site 0018, +3120-5129111
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Sander Bins, Site 0028, 3110107040962
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Brant Delafontaine, Site 0017, +3293320000
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Capital Region, DK-2100
Kristoffer Rohrberg, Site 0022, +4535456353
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset Solna
Solna, Stockholms Län [se-01], 171 64
Lisa Liu, Site 0023, 46851770000
About this study
Official title: A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
The purpose of this study is to investigate the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986482, Pumitamig
- Keywords
- Immuno-oncology, Regulatory T cells, Tregs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986482Drug
Specified dose on specified days
PumitamigDrug
Also called BMS-986545, BNT327
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A | Experimental | Not described Receives: Drug: BMS-986482 |
| Part 1B1 | Experimental | Not described Receives: Drug: BMS-986482; Drug: Pumitamig |
| Part 1B2 | Experimental | Not described Receives: Drug: BMS-986482; Drug: Pumitamig |
| Part 1C | Experimental | Not described Receives: Drug: BMS-986482 |
| Part 2B1 | Experimental | Not described Receives: Drug: BMS-986482; Drug: Pumitamig |
| Part 2B2 | Experimental | Not described Receives: Drug: BMS-986482; 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 (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Measured: Up to 135 days post last treatment visit
Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0
Measured: Up to 135 days post last treatment visit
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0
Measured: Up to Day 28
Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0
Measured: Up to 135 days post last treatment visit
Number of deaths as assessed by NCI-CTCAE v5.0
Measured: Through study completion (Up to 4 years)
Secondary outcomes (4)
Concentration at the end of infusion (Cmax)
Measured: Up to 135 days post last treatment visit
Time of maximum observed concentration (Tmax)
Measured: Up to 135 days post last treatment visit
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Measured: Up to 135 days post last treatment visit
Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator
Measured: Up to 135 days post last treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start17 Feb 2025
- Primary completion4 Jan 2029 (estimated)
- Study completion5 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 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
- NCT06697197
- Sponsor's protocol ID
- CA236-0001
- Other IDs
- 2024-516602-28, U1111-1309-0886
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2024
- Last updated
- 21 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