Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer+1 More
Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug called Toripalimab to see if it is safe and effective for treating advanced cancers. The trial will also look at the drug's effects on the immune system and overall survival.

Eligible Conditions
  • Cancer
  • Advanced Malignancies

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an average of 1 year

Year 1
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Progression-Free survival (PFS)
Day 90
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Year 1
Overall survival (OS)

Trial Safety

Trial Design

4 Treatment Groups

Toripalimab 240 mg repeat dose every 14 days
1 of 4
Toripalimab 480 mg repeat dose every 14 days
1 of 4
Toripalimab 80 mg repeat dose every 14 days
1 of 4
Toripalimab 240 mg repeat dose every 21 days
1 of 4

Experimental Treatment

198 Total Participants · 4 Treatment Groups

Primary Treatment: Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody · No Placebo Group · Phase 1

Toripalimab 240 mg repeat dose every 14 days
Biological
Experimental Group · 1 Intervention: Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody · Intervention Types: Biological
Toripalimab 480 mg repeat dose every 14 days
Biological
Experimental Group · 1 Intervention: Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody · Intervention Types: Biological
Toripalimab 80 mg repeat dose every 14 days
Biological
Experimental Group · 1 Intervention: Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody · Intervention Types: Biological
Toripalimab 240 mg repeat dose every 21 days
Biological
Experimental Group · 1 Intervention: Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks (part a) or every 9 weeks (part b) through study completion, an average of 1 year

Who is running the clinical trial?

TopAlliance Biosciences, Inc.UNKNOWN
2 Previous Clinical Trials
499 Total Patients Enrolled
Shanghai Junshi Bioscience Co., Ltd.Lead Sponsor
88 Previous Clinical Trials
23,197 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
91 Previous Clinical Trials
232,262 Total Patients Enrolled
Sheng Yao, PhDStudy DirectorTopAlliance Biosciences, Inc.
2 Previous Clinical Trials
499 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.