A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Solid Tumors

Shanghai Junshi Bioscience Co., Ltd.3 sites in 1 country118 target enrollmentJuly 26, 2022

ConditionsAdvanced Solid Tumors

InterventionsJS107 Toripalimab

DrugsJS107 Toripalimab

Overview

Phase: Phase 1
Intervention: JS107
Conditions: Advanced Solid Tumors
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrollment: 118
Locations: 3
Primary Endpoint: MTD
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this phase I clinical study was to evaluate the safety and tolerability of JS107 monotherapy and combination with Toripalimab in patients with Advanced or Metastatic Solid Tumors.

Registry

clinicaltrials.gov

Start Date

July 26, 2022

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects voluntarily participated in the study with full informed consent and signed written informed consent form;
•Aged ≥18 years and ≤75 years when the subject signed the informed consent;
•Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ;
•Provide past tumor samples or fresh tumor tissue biopsy samples;
•The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale;
•The expected survival is ≥3 months;
•There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria;
•Any adverse events and/or complications resulting from prior treatment, including surgery or radiation therapy, that have been adequately resolved to level 0 or 1 (according to the NATIONAL Cancer Institute Standard for General Terminology of Adverse Events (NCI-CTCAE 5.0) or to the level specified in the inclusion criteria; Any grade of hair loss/pigmentation and other long-term toxicity caused by treatment, except those that are irreversible and do not affect study dosing/compliance and patient safety at the discretion of the investigator;
•Good organ function；
•Within 7 days prior to the first dose, women of reproductive age must be confirmed as having a negative serum pregnancy test and consent to use effective contraception during the duration of study drug use and for 6 months after the last dose. Male patients with a female partner of reproductive age agreed to use effective contraception during the study drug use period and for 6 months after the last dose.

Exclusion Criteria

•Prior treatment with drugs or other therapies targeting CLDN18.2;
•A history of severe allergic reactions to other monoclonal antibodies or to any component of JS107, or to other drugs or excipients involved in the trial protocol ;
•Received radiotherapy (except palliative radiotherapy for symptom control), chemotherapy, targeted therapy, endocrine therapy and other antitumor therapies, or other investigational drugs within 4 weeks before the administration of the first dose;
•Received any monoclonal antibody or antibody conjugate within 4 weeks prior to administration of the first study drug or within 5 half-lives (depend on whichever is shorter);
•Persons who have an immunodeficient disease or the other chronic immunosuppressive therapy, or who have received systemic immunomodulatory drugs (including, but not limited to, interferon or IL-2) within 14 days before first dose or within the 5 half-life of the drug (depend on whichever is longer), or received systemic glucocorticoid therapy (10mg daily of prednisone or equivalent glucocorticoids) or other systemic immunosuppressive therapy within 14 days before first dose;
•Received any live vaccine (e.g. influenza vaccine against infectious diseases, chickenpox vaccine, etc.) within 14 days before first dose;
•Serious infection (CTCAE\> grade 2) occurred within 14 days before the first dose;
•Patients with other malignant tumors except for the tumor treated in the study within 5 years prior to the administration of the first study drug (exceptions included: cured malignancies that had not recurred within 3 years prior to study enrollment; Completely resected basal and squamous cell skin cancers; Complete resection of any type of carcinoma in situ, etc.);
•Major organ surgery was performed or significant trauma was present within 4 weeks before the first administration of the study drug;
•Weight loss 10% within 2 months before drug administration, or other indicators of severe malnutrition, or body mass index (BMI)\<17.5 at the time of signing the informed consent.