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A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of PM8002 Injection with Chemotherapy as Second-Line Therapy in Unresectable Neuroendocrine Neoplasm
Led by Biotheus Inc. · Updated on 2024-12-19
60
Participants Needed
13
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating PM8002, a bispecific antibody targeting PD-L1 and VEGF, in combination with the chemotherapy regimen FOLFIRI as a second-line treatment for patients with neuroendocrine neoplasm (including NEC and Ki-67655% G3 NET) who have not responded to first-line platinum-based chemotherapy. This phase II, single-arm study aims to assess the effectiveness and safety of this combination therapy in this patient group. Participants will receive PM8002 plus FOLFIRI through intravenous infusions every two weeks until their disease progresses or they experience intolerable side effects, for up to a maximum of 2 years. This treatment approach is being studied to understand how well it works and how safe it is for patients with unresectable neuroendocrine neoplasms. During the study, participants will undergo regular evaluations including tumor measurements according to RECIST v1.1 criteria, monitoring of treatment-related adverse events up to 30 days after the last treatment, and assessments of disease control, response duration, progression-free survival, and overall survival for up to approximately 2 years. Organ function and performance status will be monitored to ensure participant safety throughout the trial.
CONDITIONS
Brief Title
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial-related procedures
- Age 18 years or older
- Confirmed Ki-67655% G3 NET or neuroendocrine carcinoma by pathological diagnosis
- Failed first-line platinum-based chemotherapy
- Adequate organ function
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable tumor lesion according to RECIST v1.1
You will not qualify if you...
- History of severe allergic disease or severe drug allergy to any study drug component
- Evidence or history of severe bleeding tendency
- History of severe cardiovascular disease within the past 6 months
- Unable to provide formalin-fixed-paraffin-embedded tumor samples during screening
- Current uncontrolled pleural, pericardial, or peritoneal effusions
- History of allogeneic hematopoietic stem cell or organ transplantation
- History of alcohol, psychotropic substance, or drug abuse
- HIV infection or acquired immunodeficiency syndrome
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive PM8002 combined with FOLFIRI via intravenous infusion every 2 weeks until disease progression or intolerable toxicity, for a maximum of 2 years.
Biweekly visits for treatment administration
Duration - 30 days after last treatment
Participants are monitored for treatment-related adverse events and overall health for 30 days after the last treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 13 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
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2
Fujian Province Cancer Hospital
Fuzhou, Fujian, China
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3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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5
Jingzhou First People's Hospital
Jingzhou, Hubei, China
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6
Union Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
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7
Hunan Cancer Hospital
Changsha, Hunan, China
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8
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
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9
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
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10
Shandong Cancer Hospital
Jinan, Shandong, China
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11
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
Kunming, Yunnan, China
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12
Chinese PLA General Hospital
Beijing, China
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13
ZhongShan Hospital Fudan University
Shanghai, China
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Research Team
J
Jia Song
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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