A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid… (NCT05502393) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors
China133 participantsStarted 2022-07-26
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
. 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;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD
Timeframe: Up to approximately 12 months from first patient in.
2
RP2D
Timeframe: Up to approximately 24 months from first patient in.
. 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.);