Tolinapant

DRUG6 trials

Sponsors

Taiho Oncology Inc., Emory University, Taiho Oncology, Inc., National Cancer Institute (NCI)

Conditions

Advanced Solid Tumors and Lymphomas that are metastatic or unresectable: Cohort#1:Recurrent/metastatic head and neck squamous cell carcinoma; #2:Relapsed/refractory diffuse large B-cell lymphoma; #3:ProgressiveAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Head and Neck Carcinoma of Unknown PrimaryInvasive Breast CarcinomaLocally Advanced HER2-Negative Breast CarcinomaLocally Advanced Head and Neck Squamous Cell CarcinomaLocally Advanced Hormone Receptor-Positive Breast Carcinoma

Early Phase 1

Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

Active, not recruitingNCT05245682

Emory UniversityHead and Neck Carcinoma of Unknown Primary, Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma +3

Start: 2022-02-17End: 2027-07-21Updated: 2026-08-21

Phase 1

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)

TerminatedNCT05403450

Taiho Oncology, Inc.Relapsed/Refractory Peripheral T-cell Lymphoma

Start: 2023-02-22End: 2026-07-01Updated: 2026-07-09

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

RecruitingCTIS2022-500391-62-00

Taiho Oncology Inc.Subjects with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL)

Start: 2023-01-19Target: 77Updated: 2025-09-23

Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer

WithdrawnNCT06393751

National Cancer Institute (NCI)Platinum-Refractory Fallopian Tube Carcinoma, Platinum-Refractory Ovarian Carcinoma, Platinum-Refractory Primary Peritoneal Carcinoma +20

Start: 2025-10-31End: 2028-02-09Updated: 2025-06-03

Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

CompletedCTIS2024-516679-33-00

Taiho Oncology Inc.Advanced Solid Tumors and Lymphomas that are metastatic or unresectable: Cohort#1:Recurrent/metastatic head and neck squamous cell carcinoma; #2:Relapsed/refractory diffuse large B-cell lymphoma; #3:Progressive, refractory or relapsed peripheral T-cell lymphoma; #4:Relapsed/refractory cutaneous T-cell lymphoma; #5: Other tumor types that may have sensitivity to ASTX660; # 6: Cervical carcinoma not responsive/relapsed after standard therapy

Start: 2017-12-01End: 2025-11-25Target: 16Updated: 2025-11-11

Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer

WithdrawnNCT06590558

National Cancer Institute (NCI)Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma +9

Start: 2025-08-04End: 2027-05-17Updated: 2025-07-03

Related Papers

Abstract CT037: Early-phase trial of IAP antagonist tolinapant and definitive radiation in cisplatin-ineligible patients with previously untreated, locally advanced head and neck cancer

Cancer Research2025-04-25

Epigenetic Priming By Hypomethylation Enhances the Immunogenic Potential of Tolinapant in T-Cell Lymphoma

Blood2023-11-022 citations

PB2358: PHASE 1-2 STUDY OF THE SAFETY, PK, PD, AND PRELIMINARY ACTIVITY OF TOLINAPANT IN COMBINATION WITH ORAL DECITABINE/CEDAZURIDINE AND ORAL DECITABINE/CEDAZURIDINE ALONE IN SUBJECTS WITH R/R PTCL

HemaSphere2023-08-01

Tolinapant, a Non-Peptidomimetic Antagonist of Inhibitors of Apoptosis Proteins, cIAP1/2 and XIAP, in Combination with the Hypomethylating Agents, Azacytidine and Decitabine Are Highly Synergistic in <i>in Vitro</i> Models of T Cell Lymphoma

Blood2022-11-151 citations