drugset / Trial / NCT05538624

A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary

NCT05538624 ↗

Phase 1/2 Terminated 14 enrolled Avenge Bio, Inc
NaSequentialOpen-labelTreatment

Summary

This is an open-label, First-in-Human, Phase 1/2, multicenter study to evaluate the safety and efficacy of a single dose of AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2). It is delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

Timeline

Start
2022-12-09
Primary completion
2024-04-01
Completion
2024-04-10

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision to close study”

Drugs

EvaluationDrugModalityDoseRoute
Subject AVB-001 Cell therapy 0.6 ug/kg Intrathecal
Subject AVB-001 Cell therapy 1.2 ug/kg Intrathecal
Subject AVB-001 Cell therapy 2.4 ug/kg Intrathecal
Subject AVB-001 Cell therapy 3.6 ug/kg Intrathecal