A Phase I Study of JS108 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2022-11-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Criteria

1. Volunteer to sign an informed consent form.

2. Age of 18-75 years (inclusive), male or female;

3. Expected survival ≥3 months;

4. Histological or cytologically confirmed locally advanced or metastatic solid tumors which progressed on standard of care or with no standard of care available;

5. Toxicity of previous antitumor therapy has recovered to ≤ grade 1 as defined by the NCI-CTCAE v5.0, except alopecia;

6. Subjects dose expansion period and clinical expansion period must have at least one measurable lesion in accordance with RECIST v 1.1;

7. Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0 or 1;

8. Subjects must be able to provide fresh or archived tumor tissue obtained within 1 year prior to inclusion in the study；

9. The organ function level must meet the protocol requirements；

10. Serum pregnancy test confirmed as negative for women of childbearing potential within 7