A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma

Subjects with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL)

Phase 1: Incidence and severity of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and dose limiting toxicities (DLTs)., Phase 2: Antitumor activity assessed by ORR using 2014 Lugano Classification (Cheson et al 2014; Cheson 2015) using computerized tomography (CT) imaging as the primary modality as assessed by the investigator.

Phase 1: Oral decitabine/cedazuridine alone arm: Incidence and severity of TEAEs including SAEs and DLTs., Phase 1 and Phase 2: PK parameters of tolinapant and oral decitabine/cedazuridine, as well as oral decitabine/cedazuridine alone, including area under the concentration-time curve (AUC), maximum observed concentration (Cmax), minimum observed concentration at steady state (Cmin), time to maximum observed concentration (Tmax), apparent elimination half life (t½), and other secondary PK parameters., Phase 2: Duration of response (DOR), complete response (CR), partial response (PR), progression-free survival (PFS), disease control rate (DCR) and overall survival (OS) using the Lugano classification (Cheson et al 2014 and Cheson 2015) using CT imaging as the primary modality. - DOR, CR, PR, PFS, DCR, and OS using the Lugano classification (Cheson et al 2014 and Cheson 2015) using CT along with PET imaging assessments., Phase 2: Anti-tumor activity (ORR, DOR, CR, PR, and PFS) based on assessment using 2014 Lugano Classification with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Cheson et al 2016). - Anti-tumor activity (ORR, DOR, DCR, CR, and PR) based on PTCL subtypes (using both pathology and molecular markers)., Phase 2: Response assessments performed by both the investigator and blinded independent central radiologist.

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