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

NCT05650580 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-05-14

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • Tarapeutics Science Inc.

    lead INDUSTRY

Principal Investigators

  • Jie Jin, MD, PhD · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-23
Primary Completion
2025-07-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05650580 on ClinicalTrials.gov