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RecruitingNCT07275242Updated Jan 15, 2026

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

A Phase 1 interventional study of SHR-A1811 Subcutaneous Injection and SHR-A1811 for Injection in Solid Tumor, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
107
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Solid Tumor
03

In context

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
  2. Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
  3. History of immunodeficiency;
  4. Clinically significant cardiovascular diseases;
  5. Known or suspected interstitial lung disease;
  6. Known hereditary or acquired bleeding thrombotic tendency;
  7. Active hepatitis and liver cirrhosis;
  8. Known allergic history of the drug components of this protocol;
  9. History of neurological or psychiatric disorders.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
107 participants (estimated)

Study arms

  • Experimental
    Low-Dose Group

    Drug: SHR-A1811 Subcutaneous Injection · Drug: SHR-A1811 for Injection

  • Experimental
    Medium-Dose Group

    Drug: SHR-A1811 Subcutaneous Injection · Drug: SHR-A1811 for Injection

  • Experimental
    High-Dose Group

    Drug: SHR-A1811 Subcutaneous Injection · Drug: SHR-A1811 for Injection

Interventions

  • DrugSHR-A1811 Subcutaneous Injection

    SHR-A1811 subcutaneous injection.

  • DrugSHR-A1811 for Injection

    SHR-A1811 for injection.

06

What researchers measure

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.

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    • Erwei Song · Contact · songew@mail.sysu.edu.cn · +86-020-81332507
    • Herui Yao · Contact · yaoherui@163.com · +86-020-81332507
    • Erwei Song · Principal investigator
    • Herui Yao · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07275242
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Dec 10, 2025
Start date
Dec 23, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 15, 2026

Study contacts

Yue Zhang
Contact
yue.zhang@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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