Clinical trial · Interventional
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
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
NCT05879055CI-TRIAL-00117410active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Neoplasm | Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| PM8002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PM8002+FOLFIRI
- description
- Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
- interventionNames
- Drug: PM8002
- Drug: FOLFIRI
Primary outcomes (2)
- measure
- Objective Response Rate
- timeFrame
- Up to approximately 2 years
- description
- Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
- measure
- Treatment related adverse events (TRAEs)
- timeFrame
- Up to 30 days after last treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.