BMS CA052-002

Gastrointestinal tumors, Thoracic tumors
Pancreatic cancer, Non-small cell lung cancer (NSCLC), Small cell lung carcinoma
other systemic therapies
This first-in-human, phase 1/2 study evaluates BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in adults with advanced solid tumours, with the primary objective of assessing safety, tolerability and determining recommended phase-2 dose(s). Adult patients with advanced or metastatic disease, measurable disease per RECIST v1.1, ECOG performance status 0–1 and documented radiographic progression after most recent therapy are eligible; protocol-defined fresh pre- and on-treatment tumor biopsies are required for biomarker analyses. Subjects are enrolled into dose-escalation and dose-expansion cohorts (part 1A–1C: escalation; part 2A–2B: expansion) receiving BMS-986340 alone or combined with BMS-936558 (nivolumab) or docetaxel as per arm. Secondary assessments include preliminary anti-tumour activity, pharmacokinetic profiling and immunogenicity evaluations.
This early-phase (phase 1/2) study evaluates a new investigational drug called BMS-986340 in adults with advanced solid tumors. The main aim is to determine safety, tolerability and the recommended dose(s) for future trials. Participants receive BMS-986340 alone or in combination with the immunotherapy nivolumab or the chemotherapy docetaxel. Tumor biopsies are collected before and during treatment for biomarker analysis. Eligible patients have advanced or metastatic disease that has progressed after standard treatments. Secondary assessments include preliminary signs of anti-tumor activity and pharmacokinetic/immunogenicity analyses.