Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
Interventional
Phase 1/Phase 2
Bristol-Myers Squibb (Voir sur ClinicalTrials)
février 2025
janvier 2029
22 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Anna PATRIKIDOU | 03/07/2026 11:45:06 | Contacter | ||
Critères
Tous
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Exclusion Criteria
- 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.