A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT04396821. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04396821
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 150 participants
Conditions and interventions
Interventions
- TST001 Drug
- Nivolumab Injection [Opdivo] Drug
- mFOLFOX6 Drug
- Gemcitabine Drug
- Albumin-Bound Paclitaxel Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2020 (Actual)
- Primary completion
- Jun 30, 2027 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Sep 29, 2026
2020 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | 85234 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| Yale University | New Haven | Connecticut | 06519 | — |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | — |
| Emory University | Atlanta | Georgia | 30033 | — |
| University of Kansas, School of Medicine | Kansas City | Kansas | 66160 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering | New York | New York | 10065 | — |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | — |
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | — |
| Gabrail Cancer Research | Canton | Ohio | 44718 | — |
| Pennsylvania Cancer Specialist Research Institute | Gettysburg | Pennsylvania | 17325 | — |
| Allegheny Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| NEXT Oncology | Austin | Texas | 78704 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04396821, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04396821 live on ClinicalTrials.gov.