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A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors

NCT05731271 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2025-12-17

No results posted yet for this study

Summary

The goal of this clinical trial is to test the safety of TST003 in patients with cancer.

The main question\[s\] it aims to answer are:

* What is the recommended dose patients can safely receive?
* How long does this drug remain in the body after administration?
* What are the side effects of this drug?
* Does your cancer respond to TST003?
* Participants on this study will get TST003 intravenously (through a needle into your vein), once every 3 weeks.
* You may need to come to the study site 2-4 times to have tests to see if you are eligible to be in the study before you begin to receive the study drug.
* After you start the study drug, you will need to return to the site several times after each dose so the physician can take vital signs, draw blood samples, and evaluate you for safety and wellbeing.
* Participants will continue taking the drug as long as they are receiving clinical benefit.
* At the end of your study participation, additional testing is required.

Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Tumor
  • Colorectal Adenocarcinoma

Interventions

DRUG

TST003

IV humanized anti-GREM1 monoclonal antibody

Sponsors & Collaborators

  • Suzhou Transcenta Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT05731271 on ClinicalTrials.gov