NCT05650580

TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Tarapeutics Science Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a open-label, dose escalation and expansion, accelerated titration combined 3+3 design, phase 1 study, to evaluate the safety and tolerability, and to determine the Recommeded Phase II Dose (RP2D) of TR115 when administered bid in patients with non-hodgkin's lymphoma or advanced solid tumors. During the dose escalation phase, Up to 6 cohorts of 1-6 0r 3-6 patients each will be treated in the study. Patients will receive study treatment until criteria for study termination are met. A safety Follow-up Visit will conducted 30 days (±7 days) after the last dose of treatment. Patients who discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, lost to follow-up, death, or until the sponsor stops the study, whichever comes first. After finishing the dose escalation phase, a dose extension phase will be initiated with additional patients included in order to further evaluate the tolerability, pharmacokinetics, and efficacy at the recommended dose that have been evaluated in the dose escalation phase. Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Tumor response will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using Lugano 2014/RECIST 1.1 criteria, assessed by the investigator.

Conditions

• Non-Hodgkin's Lymphoma, Relapsed
• Non-Hodgkin's Lymphoma Refractory
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TR115	TR115 is supplied as tablet with dosage strength of 100mg. TR115 tablet will be administered orally on a continuous twice daily (BID) schedule and a treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. TR115 tablets will be given until there appears evidence of progressive disease , intolerable toxicity, or the subject discontinues from the study treatment for other reasons. Proposed daily dose (BID): 100mg, 200mg, 400mg, 800mg, 1200mg, 1600mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the Maximum Tolerated Dose (MTD) in order to better understand safety, Pharmacokinetic (PK) or Pharmacodynamic (PD).

Timeline

• Start date: 2023-04-23
• Primary completion: 2025-07-30
• Completion: 2025-12-30
• First posted: 2022-12-14
• Last updated: 2024-05-14

Locations

1 site across 1 country: China