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

NCT04601285 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2023-06-14
Completion
2023-06-14

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04601285 on ClinicalTrials.gov