Clinical trial NCT04601285: A Phase I Study of JS108 in Patients With Advanced Solid Tumors
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
timeFrame: A minimum of 21 days after first infusion of study drug
measure: Number of participants with adverse events (AEs)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Maximum observed serum or plasma concentration (Cmax)
timeFrame: Through study completion, an average of 1 year
measure: Maximum serum drug time（Tmax）
timeFrame: Through study completion, an average of 1 year
measure: Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
timeFrame: Through study completion, an average of 1 year
measure: Volume of distribution at steady state (Vss)
timeFrame: Through study completion, an average of 1 year
measure: Terminal phase elimination half life (t½)
timeFrame: Through study completion, an average of 1 year
measure: Clearance (CL)
timeFrame: Through study completion, an average of 1 year
measure: Anti-drug antibodies (ADA)
timeFrame: Through study completion, an average of 1 year
measure: Objective Response Rate (ORR)
timeFrame: 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
measure: Duration of response (DOR)
timeFrame: 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
measure: Progression Free Survival (PFS)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: 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
measure: Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References: