Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06703177

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-12-03

876

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.

CONDITIONS

Official Title

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With 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 tumor lesion according to RECIST v1.1
  • Adequate bone marrow reserve and organ function
  • Use of contraception during the trial and negative pregnancy test for women of childbearing potential within 7 days before first dose
Not Eligible

You will not qualify if you...

  • History or symptoms of meningeal or central nervous system metastasis
  • Previous or concurrent other malignancies
  • Untreated spinal cord compression
  • Uncontrolled tumor-related pain
  • Previous antibody-coupled drug therapy with topoisomerase I inhibitor toxin or EGFR/c-Met double antibody
  • Received systemic antitumor therapy before first dose
  • Major surgery other than diagnosis or biopsy within 28 days before dosing; minor surgery within 7 days before dosing
  • Prior radiation therapy exceeding prescribed dose before study treatment
  • Use of other investigational drugs within 4 weeks before study treatment
  • Unresolved grade 3 or higher toxicities from prior anticancer therapy
  • History of interstitial or non-infectious pneumonia
  • Uncontrolled pleural or pericardial effusion; moderate or severe symptomatic ascites
  • Intestinal obstruction or symptoms within 6 months before dosing
  • Poorly controlled or severe cardiovascular disease
  • Active hepatitis B or C infection
  • History of immunodeficiency
  • Severe infection within 30 days before first dose

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

Sun Yat-Sen university cancer center

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

R

Rongfu Mao, MD

CONTACT

H

Hao Shen, BS

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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