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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
NCT04137900 · View on ClinicalTrials.gov ↗
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 |
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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. 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 499 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TopAlliance Biosciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT04137900 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, New York, Ohio. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04137900?
The interventions under investigation include: Toripalimab (DRUG), TAB004 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04137900?
This trial is sponsored by TopAlliance Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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