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)

Stopped early · Phase 1

Conditions studied: Relapsed/Refractory Peripheral T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05403450

Run by

Taiho Oncology, Inc.

People needed

33

Starts

2023-02-22

Expected to finish

2026-07-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with expected life expectancy of >12 weeks.
• Participants must have histologically confirmed R/R PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study:
• Extranodal natural killer (NK)/T-cell lymphoma nasal type.
• Enteropathy-associated T-cell lymphoma.
• Monomorphic epitheliotropic intestinal T-cell lymphoma.
• Hepatosplenic T-cell lymphoma.
• Subcutaneous panniculitis-like T-cell lymphoma.
• Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
• Angioimmunoblastic T-cell lymphoma.
• Follicular peripheral T-cell lymphoma.
• Nodal peripheral T-cell with T-follicular helper (THF) phenotype.
• Anaplastic large-cell lymphoma (ALCL).
• Participants must have evidence of progressive disease and must have received at least two prior systemic therapies.
• Participants must have measurable disease by contrast-enhanced diagnostic CT (at least 1 nodal lesion >1.5 centimeters (cm) or extranodal lesions >1.0 cm).
• Participants with CD30-positive disease must have received, be ineligible for, or intolerant to brentuximab vedotin.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Acceptable organ function as per protocol.
• Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.

You may not qualify if…

• Prior treatment with tolinapant or any hypomethylating agent.
• Hypersensitivity to tolinapant or oral decitabine/cedazuridine, excipients of the drug product, or other components of the study treatment regimen.
• Poor medical risk because of systemic diseases (e.g., uncontrolled infections) in addition to the qualifying disease under study.
• Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise participant safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of tolinapant.
• A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
• Abnormal left ventricular ejection fraction.
• Congestive cardiac failure of Grade ≥3.
• Unstable cardiac disease.
• History or presence of complete left bundle branch block, third-degree heart block, cardiac pacemaker, or clinically significant arrhythmia.
• History of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy.
• Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of ≥470 milliseconds (msec) (according to either Fridericia's or Bazett's correction).
• Any other condition that, in the opinion of the investigator, could put the participant at increased cardiac risk.
• Known history of human immunodeficiency virus (HIV) infection; or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• Grade 3 or greater neuropathy.
• Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the participant to high risk of noncompliance with the protocol treatment or assessments.
• Prior anticancer treatments or therapies within the indicated time window before first dose of study treatment (tolinapant), as follows:
• Cytotoxic chemotherapy or radiotherapy within 4 weeks prior.
• Monoclonal antibodies within 4 weeks prior.
• At least 12 weeks must have elapsed since chimeric antigen receptor T-cell (CAR-T) infusion.
• Small molecules or biologics (investigational or approved) within the longer of 3 weeks or 5 half-lives before study treatment.
• Monoclonal antibody treatment for rheumatologic conditions within 4 weeks of study drug initiation.
• Concurrent second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy or superficial bladder cancer.
• Any concurrent second malignancy that is metastatic.
• Known central nervous system (CNS) lymphoma.
• Participants with a history of allogeneic transplant are excluded from this study.

Where it is running

• Hospital Universitario Marqués de Valdecilla Site#711 — Santander, Spain
• City of Hope Site #151 — Duarte, California, United States
• University of Califonia, Los Angeles — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado Anschutz Medical Campus Site #118 — Aurora, Colorado, United States
• Yale Cancer Center Site #109 — New Haven, Connecticut, United States
• Moffitt Cancer Center Site #157 — Tampa, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan Rogel Cancer Center — Ann Harbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute Site#159 — Detroit, Michigan, United States
• Rochester Skin Lymphoma Medical Group, PLLC Site #147 — Fairport, New York, United States
• NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153 — New York, New York, United States
• University of Pennsylvania Site# 160 — Philadelphia, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center Site #101 — Houston, Texas, United States
• University of Virginia Comprehensive Cancer Center — Charlottesville, Virginia, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Concord Hospital — Concord, New South Wales, Australia
• Monash Medical Center — Melbourne, Victoria, Australia
• Linear Clinical Research Site #834 — Nedlands, Australia
• Hôpital Bretonneau — Tours, Indre-et-Loire, France
• Centre Henri Becquerel — Rouen, Seine-Maritime, France
• Institut Bergonié Site#553 — Bordeaux, France
• Institut Paoli-Calmettes — Marseille, France
• CHU Saint-Eloi Site#556 — Montpellier, France

Full record on ClinicalTrials.gov

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