Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06737731

A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-01-09

300

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.

CONDITIONS

Official Title

A Phase I/II Clinical Study of SHR-1681 for 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
  • Subjects must have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that are relapsed, refractory to standard treatment, lack standard treatment, or cannot currently use standard treatment
  • Must have at least one measurable tumor lesion according to RECIST v1.1
  • ECOG performance status must be 0 or 1
  • Life expectancy must be at least 3 months
  • Must have adequate bone marrow and organ function
Not Eligible

You will not qualify if you...

  • Subjects with active central nervous system metastases or meningeal metastases
  • History of serious cardiovascular or cerebrovascular diseases
  • History of interstitial pneumonitis or suspected interstitial pneumonitis on screening imaging
  • Severe infection within 4 weeks before the first dose
  • Ongoing or previous anti-tumor therapies within 4 weeks before the first dose of study drug
  • Adverse reactions from previous anti-tumor treatments have not improved to Grade 1 or below 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

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

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Research Team

F

Fei Qiu

CONTACT

T

Ting Lu, M.M

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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A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors | DecenTrialz