A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary
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ClinicalTrials.gov Identifier: NCT05538624 |
Recruitment Status :
Terminated
(Sponsor Decision to close study)
First Posted : September 14, 2022
Last Update Posted : April 24, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 22, 2022 | ||||
First Posted Date ICMJE | September 14, 2022 | ||||
Last Update Posted Date | April 24, 2024 | ||||
Actual Study Start Date ICMJE | December 9, 2022 | ||||
Actual Primary Completion Date | April 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: In this two-part study, Part 1 is the Dose Escalation Phase; Part 2 is the Dose Expansion Phase. Masking: None (Open Label)Masking Description: Not applicable in this open-label trial. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Part 1 escalating AVB-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 AVB-001 at the MTD/RP2D
Part 1: one of four ascending doses of AVB-001 planned for IP, single dose administration at each dose level cohort of the Dose Escalation Phase. Part 2: a single dose of AVB-001 at the MTD/RP2D level (determined in Part 1) to be further evaluated in the Dose Expansion Phase. Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
14 | ||||
Original Estimated Enrollment ICMJE |
44 | ||||
Actual Study Completion Date ICMJE | April 10, 2024 | ||||
Actual Primary Completion Date | April 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT05538624 | ||||
Other Study ID Numbers ICMJE | AVB-1A-101 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Avenge Bio, Inc | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Avenge Bio, Inc | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Avenge Bio, Inc | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |