Subcutaneous SHR-A1811 injections for adults with solid tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial testing subcutaneous SHR-A1811 injections in adults with histologically confirmed solid tumors. The main goals are to measure pharmacokinetics and to characterize safety, tolerability, and preliminary efficacy. Eligible participants have ECOG 0–1, at least one measurable lesion per RECIST v1.1, adequate organ function, and an expected survival of ≥12 weeks, while patients with recent major surgery, active hepatitis or cirrhosis, immunodeficiency, significant cardiac disease, interstitial lung disease, bleeding tendencies, or relevant drug allergies are excluded. The trial is conducted at Sun Yat-sen Memorial Hospital in Guangzhou and involves scheduled dosing and follow-up visits for safety monitoring and tumor assessments.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yue Zhang
• Email: yue.zhang@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.