Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: TopAlliance Biosciences

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of Toripalimab, 2) evaluate antitumor activity of Toripalimab; 3) determine the immunogenicity of Toripalimab; 4) evaluate overall survival. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of Toripalimab, 2) evaluate pharmacodynamic effects of Toripalimab on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. 3) evaluate the utility of PD-L1 \& additional exploratory markers as biomarkers that could aid in selection of appropriate subjects for TAB001 therapy, and 4) identification of additional biomarkers correlating with response to treatment with TAB001.

Eligibility Criteria

Treatment Details

2Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment1 Intervention

Indication specific dose cohorts: Esophageal Cancer, Gastric Cancer/GEJ, Biliary Tract Cancer, Soft Tissue Sarcoma (excluding Leiomyosarcoma) or Chondrosarcoma, Neuroendocrine Cancer, and other tumors (including Nasopharyngeal Cancer (NPC), Hepatocellular Carcinoma (HCC), MSI-H/dMMR tumors).

Group II: Part AExperimental Treatment1 Intervention

Sequential dose escalation (3+3)

Toripalimab is already approved in China, United States for the following indications:

🇨🇳 Approved in China as Loqtorzi for: