Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07068932

A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-08-26

102

Participants Needed

2

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).

CONDITIONS

Official Title

A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • ECOG performance status of 0 or 1
  • Histologically or cytologically confirmed malignant tumor
  • Failed standard therapy, intolerant to standard therapy, or no standard treatment available
  • Adequate organ function
  • Voluntary participation with ability to provide written informed consent
  • Expected survival of at least 12 weeks
  • Measurable lesions required for dose-expansion phase
  • Agreement to use contraception from consent through 60 days after last dose
Not Eligible

You will not qualify if you...

  • Prior treatment with the same class of investigational drug
  • Confirmed or suspected central nervous system tumor involvement
  • Uncontrolled tumor-related pain
  • Active autoimmune disease or history of immunodeficiency including HIV
  • Clinically significant cardiovascular disease history
  • Known hypersensitivity to investigational drug components
  • Major surgery or significant trauma within 4 weeks before first dose
  • Diagnostic or superficial surgery within 7 days before first dose
  • Planned major surgery during the study
  • Adverse events from prior therapy not recovered to CTCAE Grade 1 or better
  • Severe infection within 4 weeks or active infection within 2 weeks before first dose
  • History of cerebrovascular accident within 6 months before first dose
  • Other active malignancies within 2 years prior or concurrent malignancies
  • Any other condition making participation unsuitable as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

2

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

J

Jie Shen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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