Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
Public ClinicalTrials.gov record NCT03474640. 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 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects With Advanced Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of Toripalimab, 2) evaluate antitumor activity of Toripalimab; 3) determine the immunogenicity of Toripalimab; 4) evaluate overall survival. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of Toripalimab, 2) evaluate pharmacodynamic effects of Toripalimab on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. 3) evaluate the utility of PD-L1 \& additional exploratory markers as biomarkers that could aid in selection of appropriate subjects for TAB001 therapy, and 4) identification of additional biomarkers correlating with response to treatment with TAB001.
Study identification
- NCT ID
- NCT03474640
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 184 participants
Conditions and interventions
Conditions
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
- Feb 21, 2018 (Actual)
- Primary completion
- Jun 7, 2022 (Actual)
- Completion
- Jul 7, 2022 (Actual)
- Last update posted
- Nov 22, 2024
2018 – 2022
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sarcoma Oncology Research Center | Santa Monica | California | 90404 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| University of Miami Hospital Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Florida Cancer Specialists | Sarasota | Florida | 34238 | — |
| University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic-Rochester | Rochester | Minnesota | 55901 | — |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | — |
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44101 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02906 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
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 NCT03474640, 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 Nov 22, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03474640 live on ClinicalTrials.gov.