A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Humanized Monoclonal Antibody Specific to B- and T- Lymphocyte Attenuator, BTLA (JS004) Injection in Patients With Advanced Solid Tumors

Shanghai Junshi Bioscience Co., Ltd.11 sites in 1 country156 target enrollmentApril 12, 2021

ConditionsMelanoma Renal Carcinoma Urothelial Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Melanoma
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrollment: 156
Locations: 11
Primary Endpoint: To evaluate the safety and tolerability of JS004 injection alone and in combination with Toripalimab in patients with advanced solid tumors.
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period.

Screening period: Subjects will be included in the screening period after signing the informed consent form (ICF). The screening period is up to 28 days, subjects will enter the study treatment period if they meet all the inclusion criteria and none of exclusion criterion.
Treatment period: Subjects will be allocated to the designated dose group to receive corresponding treatment in accordance with the progress of study. Subjects in dose escalation phase will receive DLT observation at first, and upon completion of DLT observation, the subjects will continue their administration at the original dose if they are tolerated as judged by investigator, until progression of disease, intolerable toxicity or other reasons specified in the protocol. Subjects in the dose extension phase receive appropriate study treatment until disease progression, intolerance of toxicity, or other causes specified in the protocol occur. Response evaluation criteria in solid tumors (RECIST v1.1) will be used for efficacy evaluation every 9 weeks (±7 days) in the first year and every 12 weeks (±7 days) in the 2nd year and thereafter.
Follow-up period: A safety follow-up visit is required 30 days (±7 days) after the last dose of study drug or before the initiation of new antitumor therapy. If the new antitumor therapy has not been initiated, additional safety follow-up should be completed 90 days (±7 days) after the last dose as far as possible.

Registry

clinicaltrials.gov

Start Date

April 12, 2021

End Date

August 31, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Only the patients meeting the following criteria are eligible to participate in the study:
•Voluntarily signed written informed consent form;
•Age ≥18 and ≤70 years at the time of signing informed consent form, male or female;
•Life expectancy ≥ 3 months;
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
•Patients with histologically or cytologically confirmed advanced solid tumors: patients with advanced solid tumors who have failure in standard of care, cannot tolerate standard of care, refuse and/or have no standard of care (melanoma, renal carcinoma and urothelial carcinoma);
•At least one measurable lesion as target lesion (RECIST v1.1);
•Agree to provide tumor tissue specimen ( fresh biopsied sample before treatment should be provided as far as possible, the archived sample within two years is acceptable for the patients who cannot provide fresh biopsied sample before treatment);
•Adequate organ function as indicated by the laboratory results during the screening period;
•Use of effective contraceptive methods during the study for male subjects of reproduction ability or female subjects of childbearing potential, and continuation of contraception for 6 months after the end of treatment;

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of JS004 injection alone and in combination with Toripalimab in patients with advanced solid tumors.

Time Frame: 2 years

Including incidence of dose limiting toxicity (DLT); incidence and severity of adverse event (AE), serious adverse event (SAE) and immune related adverse event (irAE); laboratory results with clinical significance and other tests with abnormal results.

Determine the maximum tolerated dose (MTD)/recommended extended dose (RDE) of JS004 injection monotherapy and combination with Toripalimab in patients with advanced solid tumors.

Time Frame: 2 years

The maximum tolerated dose (MTD) is defined as the maximum dose at which \<1/3 subjects experience any DLTs and at least 6 evaluable subjects are required at each dose level.

Secondary Outcomes

To preliminarily evaluate the efficacy of JS004 injection as a single drug and combined with Toripalimab.(2 years)
To evaluate the pharmacokinetic profile of JS004 Injection as a single drug and combined with Toripalimab.(2 years)