OncRef

Clinical Trial: NCT05403450

A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)

Status:

TERMINATED

Phase:

Phase 1

Lead Sponsor:Taiho Oncology, Inc.
Information Provided By:Taiho Oncology, Inc.
Last Update Posted:2026-10-08

Study Overview

Brief Summary

The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.

As no safe and tolerable dosing for the combination of tolinapant and decitabine/cedazuridine was identified based on protocol defined criteria, Sponsor decided to halt recruitment and to not conduct Phase 2 of the study.

Official Title

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

Conditions

Relapsed/Refractory Peripheral T-cell Lymphoma

Intervention / Treatment

  • Drug: Tolinapant
  • Drug: Decitabine + Cedazuridine

Other Study ID Numbers

  • ASTX660-03
  • 2022-500391-62-00

Start Date (Actual)

2023-02-22

Primary Completion Date (Actual)

2024-12-16

Study Completion Date (Actual)

2026-07-01

Enrollment (Actual)

33

Study Type

Interventional

Phase

Phase 1