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

NCT04866641 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-30

No results posted yet for this study

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

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

T-1201 Injection 100 mg Kit

T-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.

Sponsors & Collaborators

  • Taivex Therapeutics Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2026-06-30
Completion
2027-07-31
FDA Drug
Yes

Countries

  • Taiwan

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 NCT04866641 on ClinicalTrials.gov