Clinical trial · Interventional
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Gastric/Gastroesophageal Junction Adenocarcinoma | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Microsatellite Stable Colorectal Cancer | — | UNRESOLVED | — |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-936558-01 | Drug | — | UNRESOLVED |
| BMS-986340 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Pumitamig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Part 1A: BMS-986340 Dose Escalation
- interventionNames
- Drug: BMS-986340
- type
- EXPERIMENTAL
- label
- Part 2A: BMS-986340 Dose Expansion
- interventionNames
- Drug: BMS-986340
- type
- EXPERIMENTAL
- label
- Part 1B: BMS-986340 + Nivolumab Dose Escalation
- interventionNames
- Drug: BMS-986340
- Drug: BMS-936558-01
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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 Criteria * Women who are pregnant or breastfeeding. * Primary central nervous system (CNS) malignancy. * Untreated CNS metastases. * Leptomeningeal metastases. * 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. * 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. * Uncontrolled or significant cardiovascular disease. * Major surgery within 4 weeks of study drug administration. * History of or with active interstitial lung disease or pulmonary fibrosis. * Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (0)
Data not yet available