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

Last updated: November 13, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

SHR-3821 injection

Clinical Study ID

NCT06618651
SHR-3821-101
  • Ages 18-75
  • All Genders

Study Summary

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.

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 the trial.

Exclusion

Exclusion Criteria:

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

  2. Uncontrollable tumor-related pain.

  3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion withclinical symptoms.

  4. Received systemic antitumor therapy before the first dose.

  5. Treated with similar target therapy as SHR-3821 before the first dose.

  6. Received systemic anticancer treatments 4 weeks prior to the initiation of the studytreatment.

  7. Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.

  8. Current or History of ILD.

  9. Active severe digestive disease.

  10. Previous or co-existing malignancies.

  11. History of severe hypersensitivity reactions to either the drug substances orinactive ingredients of SHR-3821.

  12. Active hepatitis B or active hepatitis C.

  13. Other inappropriate situation considered by the investigator.

Study Design

Total Participants: 162
Treatment Group(s): 1
Primary Treatment: SHR-3821 injection
Phase: 1
Study Start date:
November 13, 2024
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • West China Hospital of Sichuan Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • West China Hospital of Sichuan Hospital

    Chengdu 1815286, Sichuan 1794299 610000
    China

    Active - Recruiting

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