Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07231211

A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

Led by Shanghai Shengdi Pharmaceutical Co., Ltd · Updated on 2026-01-09

258

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.

CONDITIONS

Official Title

A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form
  • Age range: 18-75 years old, both male and female are welcome
  • Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment
  • Have at least one measurable tumor lesion per RECIST v1.1
  • ECOG performance status of 0-1
  • Life expectancy 262 12 weeks
  • Adequate bone marrow and organ function
Not Eligible

You will not qualify if you...

  • Patients with active central nervous system metastases or meningeal metastases
  • Systemic antitumor therapy was received 4 weeks before the start of the study
  • Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion
  • Have poorly controlled or severe cardiovascular disease
  • Subjects with active hepatitis B or active hepatitis C
  • Adverse reactions of previous anti-tumor treatment have not recovered to Grade 261 per NCI-CTCAE v5.0

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

Y

Yunpeng Jin

CONTACT

Y

Yuting Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

6

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