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Phase I Clinical Study of SHR-5495 in the Treatment of Patients With Advanced Malignant Tumors

NCT06059508 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-07

No results posted yet for this study

Summary

This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.

Conditions

  • Advanced Malignant Tumor

Interventions

DRUG

SHR-5495 for injection

SHR-5495 for injection

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT06059508 on ClinicalTrials.gov