NCT05538624

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

A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Expansion Study of AVB-001, an Intraperitoneally Administered, Cell-Generated, Human IL-2 Immunotherapy in Patients With Platinum-Resistant, High-Grade, Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Avenge Bio, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 (IL-2). It is delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube. The study will be conducted in two parts. Part 1 is the Dose Escalation Phase using a Bayesian optimal interval (BOIN) model-assisted design in which a single dose of 1 of 4 dose levels of AVB-001 will be administered intraperitoneally (IP) in up to 24 patients. The four ascending dose levels of AVB-001 are targeted to produce hIL-2 levels of 0.6, 1.2, 2.4, and 3.6 μg hIL-2/kg/day. The purpose of Part 1 is to determine the maximally tolerated dose (MTD)/recommended Phase 2 dose (RP2D) level. Part 2 is the Dose Expansion Phase 2 in which a single dose of AVB-001 at the RP2D will be administered in up to 20 additional adult patients with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube. Additional expansion cohorts may be opened in Part 2 either as monotherapy or as an exploratory combination strategy.

Conditions

• Neoplasm, Ovarian
• Fallopian Tube Cancer
• Primary Peritoneal Cavity Cancer
• Adenocarcinoma Ovary
• Serous Adenocarcinoma of Ovary
• Serous Adenocarcinoma of Primary Peritoneum
• Primary Peritoneal Carcinoma
• High Grade Serous Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AVB-001 (Dose Escalation Phase)	One of four ascending doses of AVB-001 planned for IP, single dose administration in each dose level cohort of the Dose Escalation Phase (Part 1).
DRUG	AVB-001 (Dose Expansion Phase)	The MTD/RP2D as determined in the Dose Escalation Phase will be further evaluated in the Dose Expansion Phase.

Timeline

• Start date: 2022-12-09
• Primary completion: 2024-04-01
• Completion: 2024-04-10
• First posted: 2022-09-14
• Last updated: 2024-04-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study