Clinical trial
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.
Name
JS108-001-I
Description
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.
Trial arms
Trial start
2020-10-28
Estimated PCD
2023-06-14
Trial end
2023-06-14
Status
Terminated
Phase
Early phase I
Treatment
JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort.
Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose.
Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose.
Arms:
Dose Escalation
Size
25
Primary endpoint
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
A minimum of 21 days after first infusion of study drug
Number of participants with adverse events (AEs)
Through study completion, an average of 1 year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-07-06
1 organization
1 product
1 indication
Organization
Shanghai Junshi BioscienceProduct
JS108Indication
Cancer