PM8002 in the Treatment of Patients With Advanced Solid Tumors

Launched by BIOTHEUS INC. · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PM8002, which is designed to help patients with advanced solid tumors, a type of cancer. The goal is to learn about how safe it is, how well it works, and how the body processes it. PM8002 is a special type of drug that targets two important pathways involved in cancer growth. The trial is currently looking for adult participants aged 18 to 75 who have a confirmed diagnosis of cancer and have not fully recovered from the side effects of previous treatments.

To participate, patients should have at least one measurable tumor that hasn’t been treated yet and should be in relatively good health, with an expected survival of at least 12 weeks. Participants will receive the treatment and will be monitored closely for any side effects and how the treatment affects their tumors. It’s important to note that individuals with certain medical conditions, such as severe allergies, active infections, or uncontrolled cancer spread to the brain, cannot participate in this trial. This study aims to provide more options for patients dealing with challenging cancer types.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
• • 2. Male or female aged 18 to 75 years;
• • 3. Patients with malignant tumor confirmed by histology or cytology;
• • 4. The toxicity of previous anti-tumor therapy has not been alleviated；
• • 5. Adequate organ function；
• • 6. ECOG score was 0-1;
• • 7. Expected survival \>=12 weeks;
• • 8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.
• Exclusion Criteria:
• • 1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
• • 2. Evidence of major coagulopathy or other obvious risk of bleeding;
• • 3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
• • 4. Patients with uncontrolled brain metastases should be excluded from this clinical trial;
• • 5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
• • 6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• • 7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
• • 8. Syphilis antibody positive;
• • 9. Patients with active tuberculosis (TB) are excluded;
• • 10. Pregnant or lactating women;
• • 11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.