A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
Overview
- Phase
- Phase 1
- Intervention
- JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
- Conditions
- Advanced Solid Tumors
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- Number of participants with adverse events (AEs)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose Escalation
Intervention: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
Outcomes
Primary Outcomes
Number of participants with adverse events (AEs)
Time Frame: Through study completion, an average of 1 year
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Time Frame: A minimum of 21 days after first infusion of study drug
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Secondary Outcomes
- Maximum observed serum or plasma concentration (Cmax)(Through study completion, an average of 1 year)
- Maximum serum drug time（Tmax）(Through study completion, an average of 1 year)
- Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)(Through study completion, an average of 1 year)
- Anti-drug antibodies (ADA)(Through study completion, an average of 1 year)
- Overall Survival (OS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Volume of distribution at steady state (Vss)(Through study completion, an average of 1 year)
- Objective Response Rate (ORR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Duration of response (DOR)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Progression Free Survival (PFS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)
- Terminal phase elimination half life (t½)(Through study completion, an average of 1 year)
- Clearance (CL)(Through study completion, an average of 1 year)
- Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue(Through study completion, an average of 1 year)