RecruitingPhase 1NCT05650580

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

Sponsor

Tarapeutics Science Inc.

Enrollment

26 participants

Start Date

Apr 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer drug called TR115 in patients with non-Hodgkin's lymphoma or advanced solid tumors that have come back or stopped responding to other treatments. This is an early-phase study focused on safety and finding the right dose. **You may be eligible if...** - You are 18 or older with relapsed or refractory non-Hodgkin's lymphoma or an advanced solid tumor - You have already tried standard treatments that did not work - You are in adequate health with good organ function **You may NOT be eligible if...** - You have significant heart, liver, or kidney problems - You are currently pregnant or breastfeeding - You have had certain recent prior treatments or major surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTR115

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).