Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies

Launched by ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Erythrocyte-αPD-1 conjugate for patients with advanced cancer. The goal is to find out if this treatment is safe, how it works in the body, and if it can help patients whose cancer has not responded to other treatments. Patients eligible for this study are between 18 and 75 years old and have advanced cancer that has been confirmed by a doctor. They must have already tried other treatments without success, or they may not be able to use standard treatments for various reasons.

If you join the trial, you will receive the Erythrocyte-αPD-1 treatment and be monitored closely for any side effects and how well the treatment works. It’s important to note that you need to be in generally good health and not have any serious medical conditions that could interfere with the study. Participants will also need to agree to take precautions to avoid pregnancy during the trial. This study is still in the planning stages and is not yet recruiting participants, but it represents a hopeful step forward for those with limited treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
• • 2. Regardless of gender, aged 18 to 75 years old (including threshold);
• • 3. Patients with advanced malignant tumors who have been confirmed by histopathology;
• • 4. Patients with histopathologically confirmed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment;
• • 5. ECOG≤1；
• • 6. Expected life ≥ 3 months；
• • 7. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; Pregnancy testing results for women of childbearing age within ≤ 7 days before the first trial drug administration must be negative. Women of childbearing age include premenopausal women and women within 2 years after menopause.
• Exclusion Criteria:
• • 1. People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
• • 2. Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
• • 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
• • 4. There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
• • 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
• • 6. Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
• • 7. Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment