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A Phase I Study Of JS015 in Patients With Advanced Solid Tumors

NCT05770310 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-03-15

No results posted yet for this study

Summary

This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of JS015 in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） was determined based on the safety, pharmacokinetics, and initial efficacy data of the dose escalation and extension.

Conditions

  • Advanced Solid Cancer

Interventions

DRUG

JS015

Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Principal Investigators

  • Jin Li, Medical Doctor · Affiliation: Shanghai Oriental Hospital

  • Jinming Yu, Medical Doctor · Shandong Cancer Hospital and Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-06-01
Completion
2025-07-01

Countries

  • China

Study Locations

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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 NCT05770310 on ClinicalTrials.gov