A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Key facts
- Where
- Candiolo, Milan, Naples, Roma, Rozzano, and Siena, ItalySee the 6 sites
- Phase
- Phase 1/2
Where in Italy
- Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaCandiolo, ItalyTaking people
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1Milan, ItalyTaking people
- Istituto Nazionale Tumori IRCCS Fondazione PascaleNaples, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRoma, ItalyTaking people
- HumanitasRozzano, ItalyTaking people
- ospedale le scotte-U.O.C. Immunoterapia OncologicaSiena, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT04895709
- Record updated
- 17 August 2026
- Original description
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.Read full original descriptionShow less
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
Inclusion: Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis; Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable; Eastern Cooperative Oncology Group Performance Status of 0 or 1; Radiographically documented progressive disease on or after the most recent therapy; Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated; Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
Exclusion: Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment; Prior organ or tissue allograft; Major surgery within 4 weeks of study drug administration; Primary central nervous system (CNS) malignancy; Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment; Active, known, or suspected autoimmune disease; Uncontrolled or significant cardiovascular disease; History of or with active interstitial lung disease or pulmonary fibrosis; Women who are pregnant or breastfeeding; Untreated CNS metastases; Leptomeningeal metastases; Other protocol-defined inclusion/exclusion criteria apply.