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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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).
The MTD/RP2D as determined in the Dose Escalation Phase will be further evaluated in the Dose Expansion Phase.
National Cancer Institute
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
MD Anderson Cancer Center
Houston, Texas, United States
Incidence of dose limiting toxicities (DLTs) of IP administered AVB-001 to determine the MTD and RP2D in the Dose Escalation Phase (Part 1)
Time frame: 4 weeks
Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs) of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
Time frame: 1 year
Investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
Time frame: 1 year
Investigator-assessed ORR per RECIST v1.1 of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
Time frame: 1 year
Investigator-assessed ORR per the modified RECIST guideline for immunotherapy (iRECIST) of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
Time frame: 1 year
Duration of response (DOR) in the Dose Escalation Phase (Part 1)
Time frame: 1 year
Progression Free Survival (PFS) in the Dose Escalation Phase (Part 1)
Time frame: 1 year
Overall survival (OS) in the Dose Escalation Phase (Part 1)
Time frame: 1 year
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Escalation Phase (Part 1)
Time frame: 1 year
Incidence of treatment-emergent AEs and SAEs of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
Time frame: 1 year
Investigator-assessed ORR per iRECIST of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
Time frame: 1 year
DOR in the Dose Expansion Phase (Part 2)
Time frame: 1 year
PFS in the Dose Expansion Phase (Part 2)
Time frame: 1 year
OS in the Dose Expansion Phase (Part 2)
Time frame: 1 year
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Expansion Phase (Part 2)
Time frame: 1 year
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