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Protocol # 21-481

Status

Recruiting

Description

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.

Condition

  • Advanced Unresectable Solid Tumor
  • Metastatic Solid Tumor

Interventions

  • TAB004
  • Toripalimab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome:

  • Objective Response Rate (ORR) by RECIST 1.1
  • Duration of Response (DOR) by RECIST 1.1
  • Disease Control Rate (DCR) by RECIST 1.1
  • Time to response (TTR) by RECIST 1.1
  • Progression-free survival (PFS) by RECIST 1.1
  • Overall survival (OS) by RECIST 1.1
  • BTLA receptor occupancy (RO) of blood
  • Maximum Plasma Concentration (Cmax) after single dose injection of TAB004 and for toripalimab
  • Peak Time (Tmax) after single dose injection of TAB004 and for toripalimab
  • Area Under the Curve (AUC) after single dose injection of TAB004 and for toripalimab
  • t1/2 after single dose injection of TAB004 and for toripalimab
  • Plasma clearance (CL) after single dose injection of TAB004 and for toripalimab
  • Apparent volume of distribution (V) after single dose injection of TAB004 and for toripalimab
  • Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of TAB004 and for toripalimab
  • Apparent volume of distribution of steady state (Vss) after multiple dose injection of TAB004 and for toripalimab
  • The presence of anti-drug antibody (ADA) after multiple dose injection of TAB004 and for toripalimab
  • Accumulation after multiple dose in injection of TAB004 and for toripalimab

Enrollment

499

Study Start Date

October 30, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

Source

Shanghai Junshi Bioscience Co., Ltd.

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

Clinicaltrials.gov Identifier

NCT04137900

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.