Studieoverzicht

Study name: CA120-1001

Histology NSCLC
Tumor stage Stage IV
Host / recruiting sites UMC Groningen
Enrollment Recruiting
Therapy line Later line (≥2L)
Design

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.
Contact information