A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors

NCT05502393 | Unknown Phase 1 DMC

• 1 other identifier: JS107-001-I
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• MTD

  Determine maximum tolerated dose (MTD, if possible)

  Up to approximately 12 months from first patient in.

• RP2D

  Recommended phase II dose (RP2D) for JS107 monotherapy and combination therapy

  Up to approximately 24 months from first patient in.

Secondary Outcomes (3)

• Drug concentrations

  Up to approximately 24 months from first patient in.

• Immunogenicity

  Up to approximately 24 months from first patient in.

• ORR

  Up to approximately 24 months from first patient in.

Study Arms (2)

JS107

EXPERIMENTAL

Drug: JS107

JS107 combination with Toripalimab

EXPERIMENTAL

Drug: JS107; Drug: Toripalimab

Interventions

JS107 DRUG

JS107, i.v., q3w

JS107; JS107 combination with Toripalimab

Toripalimab DRUG

Toripalimab i.v., q3w

JS107 combination with 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:

• 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;
• 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.

You may not qualify if:

• 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.
• The following conditions were present within 6 months prior to the first study dose: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure , hypertensive crisis, or hypertensive encephalopathy; patients with known hypertension, coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \<50% must be treated with optimal stabilization as determined by the treating physician medical plan;
• Pericardial effusion, pleural effusion or abdominal effusion with clinical symptoms, signs or requiring symptomatic treatment;
• Poorly controlled pain related;
• The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be manifested by the onset of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth;
• Active infection, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB tests according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive);

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (3)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Ruihua Xu, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruihua Xu, M.D

CONTACT

86 020-87342479; xurh@sysucc.org.cn

Furong Liu, Medicie Postgraduate

CONTACT

86 020-87342479; liufr@sysucc.org.cn

Study Design

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

Model Details: Sequential

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 16, 2022
• Study Start: July 26, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)