CA1201001 is a Phase 1/2, FIH, multi-center, open-label study of oral BMS-986449 administered as a single agent and in combination with nivolumab in participants with advanced solid tumors.
Intervention
Part 1A: BMS-986449 will be administered orally (PO) once daily (QD) with dose escalation at 5, 10 (starting dose), 20, 40, and 80 mg (up to 200 mg in 40-mg increments).
Part 1B: Participants will receive BMS-986449 PO QD and nivolumab 480 mg via intravenous (IV) infusion over 30 minutes every cycle (28 days).
Part 1C: Participants will receive BMS-986449 PO QD at RP2D.
Key outcome parameters
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and deaths based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE) v5.0
Key inclusion criteria
All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
Part 1A may have a solid malignancy of any histology.
Part 1B is restricted to participants with NSCLC.
Part 1C is restricted to participants with TNBC.
Tumor biopsy must be obtained for all participants (unless medically precluded).
Key exclusion criteria
History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death–ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) 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.
