SGT003 in people with advanced 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 first-in-human phase I/IIa study of SGT003 in patients with advanced solid tumors. The trial has a dose-escalation phase to identify a safe dose, followed by a dose-expansion phase to further evaluate safety and preliminary efficacy. Key measurements include safety, tolerability, pharmacokinetics, immunogenicity, and signs of anti-tumor activity. Eligible participants are adults 18–75 with histologically confirmed advanced solid tumors who have exhausted standard therapies or have no good options, have good organ function, and ECOG 0–1. The study is conducted at Beijing Cancer Hospital under Beijing Sungen Biomedical Technology Co., Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
2. Patients aged 18 to 75 years at the time of ICF signature.
3. Study population:

   * Phase I (dose-escalation study): Patients with advanced solid tumors confirmed histologically or cytologically, who have failed at least one standard therapy for advanced disease, are intolerant to standard therapy, or have no available standard treatment options.
   * Phase IIa (dose-expansion study): Patients with advanced solid tumors who have received at least first-line but not up to third-line standard systemic therapy and experienced disease progression or intolerance to such therapy.
4. ECOG 0 or 1.
5. Radiographic evidence (CT/MRI, etc.) of disease progression documented during or after the most recent prior treatment.
6. Patients must have adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Subjects who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunosuppressive therapy or other anti-tumor therapy within 4 weeks prior to the first administration of the investigational product.
2. Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
3. Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
4. Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
5. Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.
6. Subjects with a history of Grade ≥3 immune-related adverse events (irAEs), hypersensitivity reactions, or Grade ≥2 immune-related myocarditis.
7. Subjects with active autoimmune disease or prior autoimmune disease with a risk of recurrence. Exceptions: well-controlled type 1 diabetes, hypothyroidism controlled solely by hormone replacement therapy, and skin diseases that do not require systemic treatment.
8. Subjects with current or prior active interstitial lung disease (ILD). Subjects with radiation-induced pulmonary fibrosis that does not require steroid therapy are eligible.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Shuchang Jiang
• Email: shuchang.jiang@hotgen.com.cn
• Phone: +86 13552250017

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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.