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Monoclonal Antibodies

TST005 for Cancer

Phase 1
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days following last dose
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that targets two proteins involved in cancer growth. The study will help researchers learn if the treatment is safe and effective.

Eligible Conditions
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days following last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days following last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A - Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose(s) (RP2D)
Part B - Patient safety as characterized by frequency and severity of adverse events
Secondary outcome measures
Immunogenicity of TST005
Part A - Area under Plasma concentration vs. time curve (AUC) for TST005
Part A - Peak Plasma concentration (Cmax) for TST005
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B - Dose ExpansionExperimental Treatment1 Intervention
Participants with any kind of advanced or HPV metastatic solid tumors dosed Q3W with the Part A Q3W recommended dose of TST005
Group II: Part A - Dose EscalationExperimental Treatment1 Intervention
Dosed every 3 weeks IV with TST005, starting dose is 1 mg/kg, and 5 dose levels will be tested.

Find a Location

Who is running the clinical trial?

Suzhou Transcenta Therapeutics Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
1,605 Total Patients Enrolled
Transcenta TherapeuticsLead Sponsor
Charlie Qi, MDStudy DirectorSuzhou Transcenta Therapeutics Co., Ltd.

Media Library

TST005 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04958434 — Phase 1
Cancer Research Study Groups: Part A - Dose Escalation, Part B - Dose Expansion
Cancer Clinical Trial 2023: TST005 Highlights & Side Effects. Trial Name: NCT04958434 — Phase 1
TST005 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958434 — Phase 1

Frequently Asked Questions

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

How many research participants are involved in this experiment?

"Affirmative, clinicaltrials.gov contains evidence that this scientific experiment is currently enrolling subjects. This trial was originally posted on June 11th 2021 and has since been modified as recently as November 1st 2021. A total of 55 patients will be recruited from 3 different sites for participation in the study."

Answered by AI

Is this clinical research actively recruiting participants?

"Clinicaltrials.gov conveys that this medical trial is currently enrolling patients. This study was first announced on June 11th 2021 and has since been revised as of November 1st, 2021."

Answered by AI

What are the fundamental aims of this research initiative?

"The primary aim of this medical trial, observed over a period of 90 days following the last drug dosage, is to identify both the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dosage (RP2D). Secondary endpoints include determining the Disease Control Rate (DCR), Overall Survival rate (OS) and Time To Maximum Observed Serum concentration for TST005."

Answered by AI

Has TST005 received the go-ahead from the FDA?

"There is limited evidence on TST005's safety and efficacy, leading to it receiving a rating of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors
2021. "Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04958434.
~5 spots leftby Apr 2025
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