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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: Recruiting Phase 1 study of Metastatic Solid Tumor and Advanced Unresectable Solid Tumor, sponsored by TopAlliance Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT04137900 shows while recruiting
NCT04137900 is an interventional study that assigns participants to a tested intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap, above the 183-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (173% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT04137900's enrollment target sits among peer trials
499 4th of 52 higher than 49 of 52 other Metastatic Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Solid Tumor 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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