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TST003 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Suzhou Transcenta Therapeutics Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age at the time of informed consent.
For Phase 1a Part: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic solid tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial tests the safety of a drug (TST003) for cancer patients, looking at dose, how long it stays in the body, side effects, and effectiveness. Participants come to the site 2-4 times for tests before starting the drug, then return several times for monitoring.

Who is the study for?
Adults with certain advanced solid tumors, measurable lesions (for Phase Ib), and no standard treatment options left. They must be in good general health with proper organ function, not pregnant or nursing, and willing to use contraception. People who've had recent cancer treatments or severe illnesses are excluded.Check my eligibility
What is being tested?
TST003 is being tested for safety in cancer patients. The study will determine the safe dosage level, how long it stays in the body, side effects experienced by participants, and if it helps shrink their tumors. It's given intravenously every three weeks as long as benefits continue.See study design
What are the potential side effects?
Specific side effects of TST003 aren't listed but generally may include reactions at the infusion site, fatigue, nausea, blood count changes among others based on similar drugs' profiles; all participants will be closely monitored for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have an advanced cancer that cannot be removed by surgery.
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My cancer is advanced, cannot be surgically removed, and tests positive for GREM1.
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My cancer has worsened despite treatment and there are no standard treatments left.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function is within the required range.
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My liver tests for bilirubin, ALT, and AST are within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess Adverse events (AEs) of TST003
Assess abnormal findings related to TST003
Assess the Dose limiting toxicities of TST003
+6 more
Secondary outcome measures
Determine the formation of Anti-drug antibody (ADA) against TST003
Determine the formation of Neutralizing antibodies (NAb) against TST003
To Determine Trough serum concentration of TST003
+2 more
Other outcome measures
To assess biomarkers in tumor tissue , and the correlation between biomarkers and PK, pharmacodynamic and clinical outcomes of TST003
To assess biomarkers, in blood and the correlation between biomarkers and PK, pharmacodynamic and clinical outcomes of TST003

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 1b Part - Dose Expansion at Recommended Phase 2 doseExperimental Treatment1 Intervention
Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose,
Group II: Phase 1a Part - TST003 Dose EscalationExperimental Treatment1 Intervention
TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg

Find a Location

Who is running the clinical trial?

Suzhou Transcenta Therapeutics Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
1,548 Total Patients Enrolled

Media Library

Colorectal Cancer Clinical Trial 2023: TST003 Highlights & Side Effects. Trial Name: NCT05731271 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this clinical research?

"Affirmative. Information hosted on clinicaltrials.gov affirms that this experiment is actively enrolling volunteers; it was first published on the 8th of February 2023 and most recently modified on 15th February in the same year. 76 patients are needed to be recruited from a single location."

Answered by AI

Could you provide a tally of the participants in this research endeavor?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment is currently in progress and accepting applicants. The study was initially posted on February 8th 2023 and updated most recently on February 15th 2023. There are 76 openings at a single site for prospective participants."

Answered by AI

What are the primary objectives of this clinical trial?

"The aim of this long-term trial, which is expected to complete in one year on average, is to evaluate the dose-limiting toxicities of TST003. Other objectives include determining the maximum serum concentration and minimum trough serum concentration for TST003 as well as any anti-drug antibody formation against it."

Answered by AI

Who else is applying?

What site did they apply to?
NEXT Oncology
OHSU
Mary Crowley
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I haven’t tried any treatment.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors
2023. "A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05731271.
All > Colorectal Cancer Dallas
~35 spots leftby May 2025
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