Using PM8002 with chemotherapy for neuroendocrine neoplasms

A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm

This study is testing a new treatment combining PM8002 with chemotherapy to see if it helps people with advanced neuroendocrine tumors who didn't respond to their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biotheus Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 13 sites (Chongqing, Chongqing Municipality and 12 other locations)
• Trial ID: NCT05879055 on ClinicalTrials.gov

What this trial studies

This phase II interventional study evaluates the safety and efficacy of PM8002, a bispecific antibody targeting PD-L1 and VEGF, in combination with FOLFIRI as a second-line treatment for patients with neuroendocrine neoplasms (NEC) and Ki-67≥55% G3 NET who have failed first-line platinum-based chemotherapy. The study is designed as a single-arm trial, meaning all participants will receive the same treatment without a control group. Participants will be monitored for their response to the treatment and any adverse effects experienced during the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed Ki-67≥55% G3 NET or NEC who have not responded to first-line platinum-based chemotherapy.

Not a fit: Patients with severe allergic reactions to study drugs, uncontrolled effusions, or significant cardiovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced neuroendocrine neoplasms who have limited treatment choices.

How similar studies have performed: While this approach is novel in the context of combining PM8002 with FOLFIRI for this specific patient population, similar studies using bispecific antibodies have shown promise in other cancer types.

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.

Where this trial is running

Chongqing, Chongqing Municipality and 12 other locations

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Province Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Jingzhou First People's Hospital — Jingzhou, Hubei, China (Recruiting)
• Union Hospital Tongji Medical College of Hust — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The Central Hospital of Yongzhou — Yongzhou, Hunan, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University) — Kunming, Yunnan, China (Recruiting)
• Chinese PLA General Hospital — Beijing, China (Recruiting)
• ZhongShan Hospital Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jianming Xu — Chinese PLA General Hospital
• Study coordinator: Jia Song

Conditions Neuroendocrine Neoplasm; Second line; NEC; G3 NET