Subcutaneous SHR-A1811 injections for adults with solid tumors.

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

This trial will test SHR-A1811 given under the skin to see if it is safe, tolerable, and how the body processes it in adults with measurable solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07275242 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed solid tumors, ECOG 0–1, at least one measurable lesion, adequate renal and hepatic function, and expected survival of ≥12 weeks.

Not a fit: Patients with recent major surgery or radiotherapy/chemotherapy, active hepatitis or cirrhosis, immunodeficiency, significant cardiovascular disease, interstitial lung disease, bleeding disorders, known allergy to study drug components, or recent other malignancies are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, SHR-A1811 could provide a new treatment option delivered by a convenient subcutaneous injection for some patients with solid tumors.

How similar studies have performed: Subcutaneous delivery of anticancer biologics has precedence in other programs, but SHR-A1811 itself appears to be a novel agent without published clinical outcome data to date.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Yue Zhang

Conditions Solid Tumor