← Back to Search

Monoclonal Antibodies

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

Phase 1
Waitlist Available
Research Sponsored by Shanghai Junshi Bioscience Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with esophageal cancer must have received, or been intolerant to, a platinum-based combination as part of their prior therapy for advanced/metastatic disease
Subjects with gastric cancer must have received, or been intolerant to, a fluoropyrimidine-platinum combination as part of their prior therapy for advanced/metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks (part a) or every 9 weeks (part b) through study completion, an average of 1 year
Awards & highlights

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
  • Advanced Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you have esophageal cancer that has spread, you must have already received or been unable to tolerate a specific type of chemotherapy called platinum-based combination therapy.
Select...
If you have stomach cancer, you must have already tried a treatment called fluoropyrimidine-platinum combination.
Select...
If you have liver cancer, you must have already tried a medicine called sorafenib for your advanced cancer.
Select...
You have a type of cancer that cannot be cured and has spread or cannot be treated anymore with standard treatments.
Select...
You have been diagnosed with certain types of cancers, such as esophageal or gastric carcinoma, nasopharyngeal carcinoma, hepatocellular carcinoma, soft tissue sarcoma, or chondrosarcoma. You must have already received at least one standard treatment for your cancer that did not work or your cancer cannot be treated with surgery. If you have MSI-H/dMMR tumors, you can also participate in the study.
Select...
If you have nasopharyngeal cancer, you must have already received a treatment that includes platinum-based drugs or were unable to tolerate it.
Select...
Your organs and bone marrow are working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks (part a) or every 9 weeks (part b) through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks (part a) or every 9 weeks (part b) through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Overall survival (OS)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Toripalimab 80 mg repeat dose every 14 daysExperimental Treatment1 Intervention
3-6 subjects (Part A)
Group II: Toripalimab 480 mg repeat dose every 14 daysExperimental Treatment1 Intervention
3-6 subjects (Part A)
Group III: Toripalimab 240 mg repeat dose every 21 daysExperimental Treatment1 Intervention
240 subjects (Part B)
Group IV: Toripalimab 240 mg repeat dose every 14 daysExperimental Treatment1 Intervention
3-6 subjects (Part A)

Find a Location

Who is running the clinical trial?

Shanghai Junshi Bioscience Co., Ltd.Lead Sponsor
112 Previous Clinical Trials
27,135 Total Patients Enrolled
TopAlliance Biosciences, Inc.UNKNOWN
2 Previous Clinical Trials
499 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,810 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this medical trial at present?

"Unfortunately, this experiment is not in need of any more participants at the moment. It was first posted on March 14th 2018 and edited as recently as December 12th 2021. For those searching for related studies, there are 2381 investigations currently seeking cancer patients and 151 dedicated to Toripalimab's Recombinant Humanized anti-PD-1 Monoclonal Antibody that require volunteers."

Answered by AI

How many participants is the research team looking to recruit for this investigation?

"At this moment, the inquiry is not actively accepting applicants. It was initially published on March 14th 2018 and last revised in December 12th 2021. If you are looking for other studies, 2381 cancer trials and 151 Toripalimab Recombinant Humanized anti-PD-1 Monoclonal Antibody experiments have positions open to enrollees."

Answered by AI

Has Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody been sanctioned by the FDA?

"The scant data available on Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody's safety and efficacy led to a score of 1 in our internal assessment."

Answered by AI

Has Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody been utilized in any previous studies?

"Toripalimab, a Recombinant Humanized anti-PD-1 Monoclonal Antibody, was first investigated in 2017 at Beijing Cancer Hospital. At this point there are 7 concluded trials and 151 ongoing ones, with many of the latter taking place at Baltimore's medical facilities."

Answered by AI

Are multiple hospitals in the city hosting this research endeavor?

"This trial is accepting patients from approximately 13 medical facilities, including the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center in Baltimore, Sidney Kimmel Comprehensive Cancer Center in Sarasota, and Florida Cancer Specialists in Houston."

Answered by AI
~28 spots leftby Mar 2025