Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06618651

A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-11-17

162

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.

CONDITIONS

Official Title

A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation and written informed consent
  • Age between 18 and 75 years, any gender
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Life expectancy of at least 3 months
  • Pathologically confirmed advanced solid tumor
  • Ability to provide fresh or archived tumor tissue
  • At least one measurable lesion according to RECIST v1.1
  • Adequate bone marrow and organ function
  • Use of contraception during the trial
Not Eligible

You will not qualify if you...

  • History or symptoms of meningeal or central nervous system metastasis
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural, pericardial, or abdominal effusion with symptoms
  • Prior systemic antitumor therapy before the first dose
  • Previous treatment with therapies similar to SHR-3821 before the first dose
  • Systemic anticancer treatment within 4 weeks before study treatment
  • Unresolved toxicities of grade 2 or higher from previous cancer therapy
  • Current or past interstitial lung disease (ILD)
  • Severe active digestive disease
  • Previous or other existing malignancies
  • History of severe allergic reactions to SHR-3821 or its ingredients
  • Active hepatitis B or C
  • Other conditions deemed inappropriate by the investigator

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

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

B

Bin bai

CONTACT

H

Hao 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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