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NCT Number: NCT07275242

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor

The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age;
  • Solid Tumor confirmed by histology or cytology;
  • ECOG score is 0 or 1;
  • An expected survival of ≥ 12 weeks;
  • At least one measurable lesion according to RECIST v1.1 criteria;
  • Have adequate renal and hepatic function;
  • Patients voluntarily joined the study and signed informed consent.

Exclusion criteria

  • With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
  • Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
  • History of immunodeficiency;
  • Clinically significant cardiovascular diseases;
  • Known or suspected interstitial lung disease;
  • Known hereditary or acquired bleeding thrombotic tendency;
  • Active hepatitis and liver cirrhosis;
  • Known allergic history of the drug components of this protocol;
  • History of neurological or psychiatric disorders.

Treatment and study plan

SHR-A1811 Subcutaneous Injection

Drug

SHR-A1811 subcutaneous injection.

SHR-A1811 for Injection

Drug

SHR-A1811 for injection.

Primary outcomes

  1. Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)

    Time frame: About 72 weeks.

  2. The incidence and severity of Dose-Limiting Toxicities (DLTs)

    Time frame: About 72 weeks.

  3. Adverse Events (AEs)

    Time frame: About 72 weeks.

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: About 72 weeks.

  2. Maximum concentration (Cmax)

    Time frame: About 72 weeks.

  3. Trough concentration (Cmin)

    Time frame: About 72 weeks.

  4. Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)

    Time frame: About 72 weeks.

  5. Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

    Time frame: About 72 weeks.

  6. Elimination half-life (t1/2)

    Time frame: About 72 weeks.

  7. Mean residence time (MRT)

    Time frame: About 72 weeks.

  8. Apparent clearance (CL/F)

    Time frame: About 72 weeks.

  9. Apparent volume of distribution at steady state (Vss/F)

    Time frame: About 72 weeks.

  10. Area under the concentration-time curve at steady state (AUCss)

    Time frame: About 72 weeks.

  11. Maximum concentration at steady state (Css, max)

    Time frame: About 72 weeks.

  12. Trough concentration at steady state (Css, min)

    Time frame: About 72 weeks.

  13. Accumulation ratio (Rac)

    Time frame: About 72 weeks.

  14. Anti-SHR-A1811 antibodies (ADA)

    Time frame: About 72 weeks.

  15. Objective Response Rate (ORR)

    Time frame: About 72 weeks.

  16. Duration of Response (DoR)

    Time frame: About 72 weeks.

  17. Disease Control Rate (DCR)

    Time frame: About 72 weeks.

  18. Progression-Free Survival (PFS)

    Time frame: About 72 weeks.

  19. Overall Survival (OS)

    Time frame: About 72 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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