A Randomized, Controlled, Open-label, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of TR115 in Patients With Relapsed and/or Refractory Peripheral T/NK-Cell Lymphoma

This is a randomized, open-label, multicenter Phase III study evaluating the efficacy and safety of TR115, an EZH2 inhibitor, versus investigator's choice (chidamide, golidocitinib, mitoxantrone liposome, or gemcitabine) in patients with relapsed and/or refractory peripheral T/NK-cell lymphoma. Approximately 180 patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). The study is being conducted at approximately 40 to 60 centers across China.

Start Date30 Jul 2026

Sponsor / Collaborator

Tarapeutics Science Inc

CTR20251176

/ CompletedPhase 1

在中国健康受试者中评估食物对TR115片药代动力学特征影响的单中心、随机、开放、单次给药、两周期、双交叉研究

[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the effect of food on the pharmacokinetic characteristics of TR115 tablets in healthy Chinese subjects

主要目的：评估中国健康受试者空腹及餐后状态下单次口服TR115片在体内的血药浓度及主要药代动力学参数，评价食物对TR115片的影响。次要目的：评价中国健康受试者空腹和餐后状态下口服TR115片的安全性。评价中国健康受试者单次口服TR115片1200mg对QT间期的影响。

[Translation]

Primary purpose: To evaluate the blood concentration and main pharmacokinetic parameters of TR115 tablets in Chinese healthy subjects after a single oral administration in fasting and postprandial state, and to evaluate the effect of food on TR115 tablets. Secondary purpose: To evaluate the safety of oral administration of TR115 tablets in Chinese healthy subjects in fasting and postprandial state. To evaluate the effect of a single oral administration of 1200mg TR115 tablets on QT interval in Chinese healthy subjects.

Start Date17 Apr 2025

Sponsor / Collaborator

Tarapeutics Science Inc

NCT05650580

/ Unknown statusPhase 1

A Phase I Clinical Study to Characterize Safety, Tolerability, and Pharmacokinetics of TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors

A phase 1 dose escalation and expanded cohort study of TR115 in the treatment of adult patients with relapsed/refractory non-hodgkin's lymphoma or advanced solid tumors.

Start Date23 Apr 2023

Sponsor / Collaborator

Tarapeutics Science Inc

100 Clinical Results associated with TR115

100 Translational Medicine associated with TR115

100 Patents (Medical) associated with TR115

100 Deals associated with TR115

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Marginal Zone Lymphoma	Phase 3	China	Tarapeutics Science Inc	30 Jul 2026
Extranodal NK-T-Cell Lymphoma	Phase 3	China	Tarapeutics Science Inc	28 May 2026
NK-cell lymphoma	Phase 3	China	Tarapeutics Science Inc	28 May 2026
Peripheral T-Cell Lymphoma	Phase 3	China	Tarapeutics Science Inc	28 May 2026
Non-Hodgkin's lymphoma refractory	Phase 1	China	Tarapeutics Science Inc	23 Apr 2023
Recurrent Non-Hodgkin Lymphoma	Phase 1	China	Tarapeutics Science Inc	23 Apr 2023
Advanced Malignant Solid Neoplasm	Phase 1	China	Tarapeutics Science Inc	17 Apr 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05650580 (EHA2026)	Phase 1	Non-Hodgkin's lymphoma refractory \| Advanced Malignant Solid Neoplasm	36	TR115 (Dose Escalation Phase)	uogijdujlu(jbxiomukvh) = TR115 exhibited a more favorable tolerability profile than historical data of other EZH2 inhibitors, with significantly lower incidence/severity of gastrointestinal adverse events krpioaekiw (oclkglosmq ) View more	Positive	12 May 2026

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