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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: Active Phase 1 study of Pancreatic Cancer and Gastric Cancer, sponsored by Suzhou Transcenta Therapeutics Co..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Characterization of TST001 safety profile including frequency and severity of adverse events that are related to treatment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
What the registry record for NCT04396821 still lists
NCT04396821 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (62% lower).
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 lists 18 locations in 14 states (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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Where NCT04396821's enrollment target sits among peer trials
150 79th of 278 higher than 198 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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