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NCT04396821 · ClinicalTrials.gov registry record · Phase 1

A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

A Phase 1 study of Pancreatic Cancer and Gastric Cancer, sponsored by Suzhou Transcenta Therapeutics Co..

Active
Registry status
Phase 1
Development phase
150
Enrollment target
18
Study locations

NCT04396821 is a Phase 1 study of Pancreatic Cancer and Gastric Cancer that is active but no longer recruiting, run by Suzhou Transcenta Therapeutics Co.. The registered enrollment target is 150 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (62% lower). The trial reports 18 study locations across 14 states.

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The verdict

NCT04396821, a Phase 1 study of Pancreatic Cancer and Gastric Cancer, is active but no longer recruiting, sponsored by Suzhou Transcenta Therapeutics Co..

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
150 participants
Enrollment target
18
Study locations

Study Summary

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.

Interventions

  • DRUG Gemcitabine
  • DRUG Nivolumab Injection [Opdivo]
  • DRUG TST001
  • DRUG mFOLFOX6
  • DRUG Albumin-Bound Paclitaxel

Study Locations (18)

Arizona

  • Banner MD Anderson - Gilbert
  • University of Arizona - Tucson

New York

  • Memorial Sloan Kettering - New York
  • Stony Brook Cancer Center - Stony Brook

Pennsylvania

  • Pennsylvania Cancer Specialist Research Institute - Gettysburg
  • Allegheny Hospital - Pittsburgh

Tennessee

  • Sarah Cannon Research Institute - Nashville
  • Vanderbilt University - Nashville

Connecticut

  • Yale University - New Haven

Florida

  • Florida Cancer Specialists - Sarasota

Georgia

  • Emory University - Atlanta

Kansas

  • University of Kansas, School of Medicine - Kansas City

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2020-05-28
Est. Completion 2026-11-30
Phase Phase 1

What the Registry Record Tells You About NCT04396821

The ClinicalTrials.gov registry entry for NCT04396821 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (62% lower). The listed sponsor is Suzhou Transcenta Therapeutics Co., which has 4 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine is the first listed.

NCT04396821 reports 18 study locations spanning 14 distinct geographic areas - top geographies include Arizona, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04396821 about?

NCT04396821 is a clinical study titled "A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors". This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, ...

What is the current status of trial NCT04396821?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2020-05-28. Estimated completion is 2026-11-30.

What conditions does trial NCT04396821 study?

This clinical trial studies the following conditions: Pancreatic Cancer, Gastric Cancer, Advanced Cancer, Gastroesophageal-junction Cancer.

What interventions are being tested in trial NCT04396821?

The interventions under investigation include: Gemcitabine (DRUG), Nivolumab Injection [Opdivo] (DRUG), TST001 (DRUG), mFOLFOX6 (DRUG), Albumin-Bound Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT04396821?

This trial is sponsored by Suzhou Transcenta Therapeutics Co., which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04396821 being conducted?

This trial has 18 study locations across Arizona, Connecticut, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.