A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
ConditionNeuroendocrine Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotheus Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form before any trial-related processes;
Aged ≥ 18 years;
Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
Subjects failed first-line platinum-based chemotherapy;
Disqualifiers
History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
Evidence and history of severe bleeding tendency;
History of severe cardiovascular diseases within 6 months;
Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);
Trial design
Design model
Single group
Treatments tested in this trial
PM8002
DrugIV infusion
FOLFIRI
DrugIV infusion
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: PM8002+FOLFIRIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Time frame
Up to approximately 2 years2
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time frame
Up to 30 days after last treatmentSecondary outcomes
1
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.
Time frame
Up to approximately 2 years2
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first
Time frame
Up to approximately 2 years3
Progression free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1)
Time frame
Up to approximately 2 years4
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov