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

Last updated: November 25, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

Bevacizumab Injection

SHR-8068

SHR-9839

Clinical Study ID

NCT06703177
SHR-1826-201
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation and written informed consent;

  2. 18-75 years older, no gender limitation;

  3. Eastern Cooperative Oncology Group (ECOG) score: 0-1;

  4. With a life expectancy ≥ 3 months;

  5. Pathologically diagnosed advanced solid tumor;

  6. Be able to provide fresh or archived tumour tissue;

  7. At least one measurable lesion according to RECIST v1.1;

  8. Adequate bone marrow reserve and organ function;

  9. Contraception is required during clinical trials, and pregnancy tests must benegative for women of childbearing age within 7 days before the first dose.

Exclusion

Exclusion Criteria:

  1. Meningeal metastasis history or clinical symptoms of central nervous systemmetastasis;

  2. Previous or co-existing malignancies;

  3. Spinal cord compression that was not treated radically by surgery and/orradiotherapy was excluded;

  4. Uncontrollable tumor-related pain;

  5. Previously received antiboy-coupled drug therapy with topoisomerase I inhibitortoxin; Previously received EGFR/c-Met double antibody;

  6. Received systemic antitumor therapy before the first dose;

  7. Have undergone major surgery other than diagnosis or biopsy within 28 days prior toinitial dosing; Minor traumatic surgery within 7 days prior to first dosing;

  8. For the first time, a study was conducted to treat patients with radiation therapyexceeding the prescribed dose before study treatment;

  9. Received Other investigational drugs treatments 4 weeks prior to the initiation ofthe study treatment;

  10. Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy;

  11. A history of interstitial pneumonia/non-infectious pneumonia;

  12. Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate orsevere ascites with clinical symptoms;

  13. Study the presence of intestinal obstruction or the presence of signs or symptoms ofintestinal obstruction 6 months before first dosing;

  14. With poorly controlled or severe cardiovascular disease;

  15. Active hepatitis B, hepatitis C;

  16. Patients with a history of immunodeficiency;

  17. Severe infection 30 days before the first dose.

Study Design

Total Participants: 876
Treatment Group(s): 9
Primary Treatment: Bevacizumab Injection
Phase: 1/2
Study Start date:
February 18, 2025
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Sun Yat-Sen university cancer center

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Sun Yat-Sen university cancer center

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.