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

Study Purpose

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05879055
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biotheus Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jianming Xu
Principal Investigator Affiliation	Chinese PLA General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Neoplasm

Additional Details

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET) who failed first-line platinum-based chemotherapy

Arms & Interventions

Arms

Experimental: PM8002+FOLFIRI

Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.

Interventions

Drug: - PM8002

IV infusion

Drug: - FOLFIRI

IV infusion

Contact a Trial Team

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