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NCT04137900 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies
A Phase 1 study of Metastatic Solid Tumor and Advanced Unresectable Solid Tumor, sponsored by TopAlliance Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 499
- Enrollment target
- 20
- Study locations
NCT04137900 is a Phase 1 study of Metastatic Solid Tumor and Advanced Unresectable Solid Tumor that is actively recruiting participants, run by TopAlliance Biosciences. The registered enrollment target is 499 participants, above the 183-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (173% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT04137900, a Phase 1 study of Metastatic Solid Tumor and Advanced Unresectable Solid Tumor, is actively recruiting participants, sponsored by TopAlliance Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 499 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB004 monotherapy and in combination with toripalimab and to describe the PK profile of toripalimab when administered with TAB004, 2) evaluate antitumor activity of TAB004 monotherapy and in combination with toripalimab; and 3) determine the immunogenicity of TAB004 monotherapy and in combination with toripalimab and to determine the immunogenicity of toripalimab when administered with TAB004. The exploratory objectives are to: 1) evaluate pharmacodynamic effects of TAB004 on its target receptor BTLA, as well as effects on the immune system; 2) evaluate biomarkers that may correlate with activity of TAB004 as monotherapy and in combination with toripalimab; 3) evaluate the utility of BTLA ligand, herpesvirus-entry mediator (HVEM), and additional exploratory biomarkers that could aid in selection of appropriate subjects for TAB004 monotherapy and in combination with toripalimab.
Conditions Studied
Interventions
- DRUG Toripalimab
- DRUG TAB004
Study Locations (20)
California
- UCLA Health Westwood Cancer Care - Los Angeles
- University of California Irvine (UCI) Medical Center - Orange
- University of California San Francisco (UCSF) Medical Center-Mission Bay - San Francisco
- University of California at San Francisio - San Francisco
New York
- Northwell Health - New Hyde Park
- New York Presbyterian / Weill Cornell Medical Center - New York
Ohio
- UC Health - University of Cincinnati Medical Center - Cincinnati
- The Ohio State University Wexner Medical Center The James Cancer Hospital and Solove Research Institute - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- University of Arizona College of Medicine-Tucson - Tucson
Florida
- Boca Raton Clinical Research (BRCR) - Boca Raton
Georgia
- Winship Cancer Institute at Emory University - Atlanta
Iowa
- University of Iowa Hospitals - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04137900
The ClinicalTrials.gov registry entry for NCT04137900 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 499 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 183-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (173% higher). The listed sponsor is TopAlliance Biosciences, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Toripalimab is the first listed.
NCT04137900 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT04137900 about?
NCT04137900 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies". The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharm...
What is the current status of trial NCT04137900?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 499 participants. The study started on 2019-10-30. Estimated completion is 2026-03.
What conditions does trial NCT04137900 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Advanced Unresectable Solid Tumor.
What interventions are being tested in trial NCT04137900?
The interventions under investigation include: Toripalimab (DRUG), TAB004 (DRUG).
Who is sponsoring clinical trial NCT04137900?
This trial is sponsored by TopAlliance Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04137900 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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