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

ClinicalTrials.gov ID: NCT04137900

Public ClinicalTrials.gov record NCT04137900. 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.

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ClinicalTrials.gov public records Last synced Sep 12, 2026, 4:00 AM EDT

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Official title

A First-in-Human, Multicenter, Open-Label, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB004 as Monotherapy and in Combination With Toripalimabin Subjects With Advanced Solid Malignancies Including Lymphoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04137900
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 1
Lead sponsor: TopAlliance Biosciences; Industry
Enrollment: 499 participants

Conditions and interventions

Conditions

Interventions

TAB004 Drug
Toripalimab 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: Oct 29, 2019
Primary completion: Feb 28, 2026
Completion: Feb 28, 2026
Last update posted: Feb 4, 2024

2019 – 2026

United States locations

U.S. sites: 24
U.S. states: 18
U.S. cities: 23

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35294	Recruiting
University of Arizona College of Medicine-Tucson	Tucson	Arizona	85721	Recruiting
UCLA Health Westwood Cancer Care	Los Angeles	California	90095	Recruiting
University of California Irvine (UCI) Medical Center	Orange	California	92868	Recruiting
University of California San Francisco (UCSF) Medical Center-Mission Bay	San Francisco	California	22902	Recruiting
University of California at San Francisio	San Francisco	California	94158	Recruiting
Boca Raton Clinical Research (BRCR)	Boca Raton	Florida	33432	Withdrawn
Winship Cancer Institute at Emory University	Atlanta	Georgia	30322	Recruiting
University of Iowa Hospitals	Iowa City	Iowa	52242	Recruiting
University of Maryland Medical Center	Baltimore	Maryland	21201	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	48201	Recruiting
Washington University	St Louis	Missouri	63110	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	68105	Suspended
Northwell Health	New Hyde Park	New York	11042	Not yet recruiting
New York Presbyterian / Weill Cornell Medical Center	New York	New York	10021	Active, not recruiting
Carolina BioOncology Institute	Huntersville	North Carolina	28078	Active, not recruiting
UC Health - University of Cincinnati Medical Center	Cincinnati	Ohio	45219	Suspended
The Ohio State University Wexner Medical Center The James Cancer Hospital and Solove Research Institute	Columbus	Ohio	43210	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	37203	Active, not recruiting
University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center	Dallas	Texas	75390-8565	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
University of Wisconsin	Madison	Wisconsin	53792	Recruiting

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 NCT04137900, 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 Feb 4, 2024 · Synced Sep 12, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04137900 live on ClinicalTrials.gov.

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