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A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
NCT04396821 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04396821
The ClinicalTrials.gov registry entry for NCT04396821 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Suzhou Transcenta Therapeutics Co., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04396821 reports 18 study locations spanning 14 distinct geographic areas — top geographies include Arizona, New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04396821?
This trial is sponsored by Suzhou Transcenta Therapeutics Co., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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