OncoMatch/Clinical Trials/NCT04137900
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
Is NCT04137900 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including TAB004 and Toripalimab for advanced unresectable solid tumor.
Treatment: TAB004 · Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Measurable disease per RECISTv1.1 and iRECIST, or RECIL 2017 for lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any systemic therapy — advanced or metastatic disease
must have received at least one line of therapy for advanced or metastatic disease
Cannot have received: anti-BTLA antibody
Exception: subjects enrolled into Part A and B only
Prior exposure to anti-BTLA, or anti-HVEM antibodies for subjects enrolled into Part A and B only
Cannot have received: anti-HVEM antibody
Exception: subjects enrolled into Part A and B only
Prior exposure to anti-BTLA, or anti-HVEM antibodies for subjects enrolled into Part A and B only
Cannot have received: allogeneic bone marrow transplantation
Prior allogeneic bone marrow transplantation
Cannot have received: solid organ transplantation
prior solid organ transplantation
Lab requirements
Blood counts
Hemoglobin 8.0 g/dL (not requiring a transfusion within 14 days prior to dosing); ANC 1.0 x 10^9/L (1,000 /mm3); Absolute lymphocyte count ≥ 0.6 x 10^9/L (600/mm3); Platelet count 75 x 10^9/L (75,000 /mm3), and not requiring platelet transfusions within the 5 days prior to dosing
Kidney function
Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance (CrCl) or 24 hour urine CrCl ≥ 40 mL/minute
Liver function
Total bilirubin ≤ 1.5 x ULN except subjects with documented Gilbert's syndrome who must have a baseline total bilirubin ≤ 3.0 mg/dL; ALT and AST ≤ 2.5 x ULN; for subjects with hepatic metastases, ALT and AST ≤ 5 x ULN
Adequate organ and marrow function, as defined below: Hemoglobin 8.0 g/dL... INR ≤ 2.0 and aPTT ≤ 1.5 x ULN; applies only to subjects who do not receive therapeutic anticoagulation; subjects receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on a stable dose
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- University of Arizona College of Medicine-Tucson · Tucson, Arizona
- UCLA Health Westwood Cancer Care · Los Angeles, California
- University of California Irvine (UCI) Medical Center · Orange, California
- University of California San Francisco (UCSF) Medical Center-Mission Bay · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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