A Study of PM8002 in Combination With Chemotherapy in Patients With NEN

Sponsor
Biotheus Inc.
Study ID
NCT05879055
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neuroendocrine Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    IV infusion
  • FOLFIRI — DRUG
    IV infusion

Study Details

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).

Key Dates

Start date
May 17, 2023
Status verified
Dec 2024
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PM8002+FOLFIRI
    Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to approximately 2 years ]

Central Contacts

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