Study of JS001 in Participants With Advanced Solid Tumors

NCT02857166 | Completed Phase 1 DMC

• 1 other identifier: Junshi-JS001-ZSZL-I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with advanced solid tumors.

Conditions

Solid Tumors

Keywords

JS001; solid tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  Up to 2 approximately years

Secondary Outcomes (17)

• Anti-Drug Antibody of JS001 in Chinese patients

  Cycle 1,2,3,5 Day 1 before JS001 infusion and 336 hours after last JS001 infusion, each cycle is 28 days.

• Objective Response Rate (ORR)

  Up to 2 approximately years

• Duration of Response (DOR)

  Up to 2 approximately years

• Progression-Free survival (PFS)

  Up to 2 approximately years

• Overall Survival (OS)

  Up to 2 approximately years

Study Arms (1)

humanized anti-PD-1 monoclonal antibody toripalimab

EXPERIMENTAL

humanized anti-PD-1 monoclonal antibody is to be injected intravenously 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg until disease progresses or unacceptable tolerability occurs.

Biological: humanized anti-PD-1 monoclonal antibody toripalimab

Interventions

humanized anti-PD-1 monoclonal antibody toripalimab BIOLOGICAL

humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.

Also known as: JS001, TAB001

humanized anti-PD-1 monoclonal antibody toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.
• at least one prior chemotherapy regimen
• age between 18 and 75 years, both gender
• has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
• life expectancy ≥ 3 months
• ECOG performance status of 0 or 1
• Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy.
• Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001.
• Has had last administration of immunosuppressive systemic steroid therapy (more than 10 mg/d prednisone or equal dose) more than 2 weeks prior to the first dose of study therapy JS001.
• Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS001. Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery. Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS001.
• The lab examination results of the screening must fulfill all of the following:
• absolute neutrophil count more than or equal to 1.5×109/ L
• platelet count more than or equal to 90×109/ L
• hemoglobin more than or equal to 90 g/L
• creatinine less than or equal to132.6µmol/L or creatinine clearance \>40 mL/min

You may not qualify if:

• Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.
• Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.
• Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has interstitial lung disease OR has had a history of pneumonitis that has required oral or IV steroids.
• Has active or suspected autoimmune disease except leukoderma,type I Diabetes, Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy, Or disease that rarely relapse without external stimulating factors.
• Had prior treatment targeting PD-1: anti-PD-1,anti-PD-L1, anti-PD-L2, cytotoxic T-lymphocyte-associated protein (CTLA), or other antibodies that targeting T cell costimulatory pathway or checkpoint.
• Has an active infection requiring systematic therapy.
• Is positive for Human Immunodeficiency Virus (HIV).
• Has active Tuberculosis.
• Has known active Hepatitis B or C.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen UniversityCancer center

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Ruihua Xu, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 5, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)