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

Recruiting at13 trial locations

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.

Research Team

Sheng Yao, PhD

Principal Investigator

TopAlliance Biosciences, Inc.

Eligibility Criteria

Inclusion Criteria

You have a type of cancer that cannot be cured and has spread or cannot be treated anymore with standard treatments.

Subjects with soft tissue sarcoma and chondrosarcoma must have radiographic evidence of progression within the previous 6 months and must have received at least 1 line of systemic therapy

Measurable disease per RECIST v1.1 and irRECIST

Exclusion Criteria

Pregnancy or breastfeeding women

Symptomatic or untreated central nervous system metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging metastases, and are off steroids

You have a history of a weak immune system since birth.

Treatment Details

Interventions

• Toripalimab (Monoclonal Antibodies)

Participant Groups

Group I: Part B Experimental Treatment 1 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 A Experimental Treatment 1 Intervention

Sequential dose escalation (3+3)

Toripalimab is already approved in China for the following indications:

Approved in China as Loqtorzi for:

• Nasopharyngeal carcinoma
• Esophageal cancer
• Small cell lung cancer

Who Is Running the Clinical Trial?

TopAlliance Biosciences

Lead Sponsor

Trials

2

Recruited

680+

TopAlliance Biosciences, Inc.

Collaborator

Trials

3

Recruited

680+

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Shanghai Junshi Bioscience Co., Ltd.

Collaborator

Trials

121

Recruited

28,800+

Dr. Jianjun Zou

Shanghai Junshi Bioscience Co., Ltd.

Chief Executive Officer since 2024

PhD in Clinical Oncology from the Second Military Medical University

Dr. Li Ning

Shanghai Junshi Bioscience Co., Ltd.

Chief Medical Officer since 2018

MD from Shanghai Medical College of Fudan University