drugset / Trial / NCT03921879

Safety and Efficacy of OT-82 in Participants With Relapsed or Refractory Lymphoma

NCT03921879 ↗

Phase 1 Unknown 50 enrolled Oncotartis, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This research study will test OT-82, which is an investigational ("research" or "experimental" ) drug. The study has two stages (Stage 1 and Stage 2). The purpose of Stage 1 is to determine the safety and tolerability and the maximum tolerated dose (MTD) or the maximum tested dose of OT-82 administered orally to participants. The purpose of Stage 2 is to determine the preliminary efficacy of OT-82 in relapsed or refractory lymphoma at the MTD or the maximum tested dose. Both parts of the study will also evaluate the pharmacokinetics (absorption, distribution, metabolism, elimination) of OT-82. OT-82 treatment slowed the growth, reduced the size, or in some cases cured certain cancers in animal studies. It is hoped that participants with relapsed or refractory lymphoma treated with OT - 82 in this study will experience slowing tumor growth and/or reduction of tumor size.

Timeline

Start
2019-07-29
Primary completion
2021-04
Completion
2021-06

Drugs

EvaluationDrugModalityDoseRoute
Subject OT-82 Unknown 16.5 mg/m2 Oral