Suspended
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Solid Tumors
What is being tested
JS107
+ Toripalimab
Drug
Who is being recruted
From 18 to 75 Years
+32 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: July 2022
Summary
Principal SponsorShanghai Junshi Bioscience Co., Ltd.
Study ContactRuihua Xu, M.DMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: July 26, 2022
Actual date on which the first participant was enrolled.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.
Official TitleA Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Solid Tumors
Principal SponsorShanghai Junshi Bioscience Co., Ltd.
Study ContactRuihua Xu, M.DMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
118 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
10 inclusion criteria required to participate
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;
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22 exclusion criteria prevent from participating
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);
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google MapsRecruiting soon
Fujian Cancer Hospital
Fuzhou, ChinaRecruiting soon
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, ChinaSuspended3 Study Centers