| Histology |
NSCLC, all subtypes
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| Tumor stage |
Stage III - IV |
| Host / recruiting site 1 |
UMC Groningen
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Enrollment |
Closed
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| Therapy line |
Later line (≥2L)
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| 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.
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| 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.
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| 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
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| 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).
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| 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.
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| Contact information |
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