Health Trials

A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

ConditionsCervical CancerGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellUrothelial CarcinomaPancreatic AdenocarcinomaMelanomaOvarian NeoplasmsTriple Negative Breast Neoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Women who are pregnant or breastfeeding.

Primary central nervous system (CNS) malignancy.

Untreated CNS metastases.

Leptomeningeal metastases.

Trial design

Treatments tested in this trial

  • BMS-986340
  • BMS-936558-01
  • Docetaxel
  • Pumitamig

Treatment groups

1,109 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Locations

47
Australia
Blacktown Hospital2148, BlacktownNew South Wales, Australia
Liverpool Hospital2170, LiverpoolNew South Wales, Australia
Princess Alexandra Hospital4102, BrisbaneQueensland, Australia
Cabrini Hospital - Malvern3144, MalvernVictoria, Australia

Sponsors and collaborators

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov