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

Shanghai Junshi Biosciences

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)

Study type: Interventional

Funder types: Other

Identifiers

NCT04601285

JS108-001-I

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Dose Escalation

Experimental group

Treatment:

Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)