drugset / Trial / NCT04866641

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

NCT04866641 ↗

Phase 1 Recruiting 40 enrolled Taivex Therapeutics Corporation
NaSequentialOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are: * The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules. * The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules. Researchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201. Participants will: Received T-1201 either once every 4 (Part A)/2 (Part B)/3 (Part C) weeks, depend on they participate in which parts of study. Visit the clinic once every 2/3 weeks for checkups and tests

Timeline

Start
2021-06-24
Primary completion
2026-06-30
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject T-1201 Unknown 100 mg Intravenous

Indications