A Study of PM8002 in Combination With Chemotherapy in Patients With NEN

Launched by BIOTHEUS INC. · May 25, 2023

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ClinConnect Summary

**Clinical Trial Summary: PM8002 Injection for Neuroendocrine Neoplasms**

This clinical trial is studying a new treatment called PM8002, which is an injection that combines two types of antibodies to help fight certain cancers known as neuroendocrine neoplasms (NEN). Specifically, the trial is looking at how well PM8002 works when given together with a chemotherapy regimen called FOLFIRI for patients whose previous treatment with platinum-based chemotherapy did not work. The goal is to see if this combination can improve the effectiveness of treatment and maintain safety for patients with aggressive forms of neuroendocrine tumors.

To be eligible for this trial, participants must be at least 18 years old, have a specific type of neuroendocrine tumor confirmed by a doctor, and have already tried and not responded to initial chemotherapy. Other requirements include having good overall health and the ability to provide a tumor sample for testing. Participants can expect regular check-ups to monitor their health and how well the treatment is working. It's important to note that individuals with certain medical history or conditions, such as severe allergies or recent serious health issues, may not be able to participate. This study is currently looking for volunteers, so if you or someone you know fits these criteria and is interested, it could be a valuable opportunity to contribute to cancer research.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent form before any trial-related processes;
• • 2. Aged ≥ 18 years;
• • 3. Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
• • 4. Subjects failed first-line platinum-based chemotherapy;
• • 5. Adequate organ function;
• • 6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
• • 7. Expected survival ≥ 12 weeks;
• • 8. Had at least one measurable tumor lesion according to RECIST v1.1;
• Exclusion Criteria:
• • 1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
• • 2. Evidence and history of severe bleeding tendency;
• • 3. History of severe cardiovascular diseases within 6 months;
• • 4. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);
• • 5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• • 6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• • 7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
• • 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• • 9. Pregnant or lactating women;
• • 10. Other conditions considered unsuitable for this study by the investigator.