Trials / Recruiting
RecruitingNCT05879055
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Biotheus Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PM8002 | IV infusion |
| DRUG | FOLFIRI | IV infusion |
Timeline
- Start date
- 2023-05-17
- Primary completion
- 2027-01-01
- Completion
- 2028-01-01
- First posted
- 2023-05-30
- Last updated
- 2024-12-19
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05879055. Inclusion in this directory is not an endorsement.