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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 : Recruiting
First Posted : September 14, 2022
Last Update Posted : October 12, 2023
Sponsor:
Information provided by (Responsible Party):
Avenge Bio, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: AVB-001 (Dose Escalation Phase) Drug: AVB-001 (Dose Expansion Phase) Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Official Title: 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
Actual Study Start Date : December 9, 2022
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Investigator-assessed ORR per RECIST v1.1 of IP administered AVB-001 in the Dose Escalation Phase (Part 1) [ Time Frame: 1 year ]
  2. 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 ]
  3. Duration of response (DOR) in the Dose Escalation Phase (Part 1) [ Time Frame: 1 year ]
  4. Progression Free Survival (PFS) in the Dose Escalation Phase (Part 1) [ Time Frame: 1 year ]
  5. Overall survival (OS) in the Dose Escalation Phase (Part 1) [ Time Frame: 1 year ]
  6. Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Escalation Phase (Part 1) [ Time Frame: 1 year ]
  7. Incidence of treatment-emergent AEs and SAEs of IP administered AVB-001 in the Dose Expansion Phase (Part 2) [ Time Frame: 1 year ]
  8. Investigator-assessed ORR per iRECIST of IP administered AVB-001 in the Dose Expansion Phase (Part 2) [ Time Frame: 1 year ]
  9. DOR in the Dose Expansion Phase (Part 2) [ Time Frame: 1 year ]
  10. PFS in the Dose Expansion Phase (Part 2) [ Time Frame: 1 year ]
  11. OS in the Dose Expansion Phase (Part 2) [ Time Frame: 1 year ]
  12. Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Expansion Phase (Part 2) [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Immunologic changes in peripheral blood and IP environments in the Dose Escalation and Dose Expansion Phases (Parts 1 and 2) [ Time Frame: 1 year (Part 1); 1 year (Part 2) ]
  2. Analysis of anti-drug antibodies (ADA) to AVB-001 in human serum in the Dose Escalation and Dose Expansion Phases (Parts 1 and 2) [ Time Frame: 1 year (Part 1); 1 year (Part 2) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have histologically confirmed, metastatic or unresectable, platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube;

    Note: For the purposes of this study, platinum-resistant is defined as a patient who has received platinum-containing chemotherapy and either has platinum-refractory disease (progressed during initial platinum-based chemotherapy) or resistant disease (relapsed within 6 months of initial platinum-containing chemotherapy) or, if previously with platinum-sensitive disease, has received at least 2 lines of platinum-containing chemotherapy and progressed.

    Note: A pathology report confirming histology will be required for enrollment.

  2. Have not received more than 5 lines of prior therapy;
  3. May have received poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, bevacizumab (or any other antiangiogenic agent), immunotherapy, or cell therapies. (Patients with germline or somatic breast cancer gene (BRCA) mutations must have progressed or been intolerant to PARP inhibitor therapy);
  4. Have an Eastern Cooperative Oncology Group performance status 0 to 1 at Screening;

  5. Meet the following laboratory criteria:

    • Absolute neutrophil count >1500/μl;
    • Hemoglobin level ≥9.0 g/dL (transfusion allowed);
    • Platelet count ≥100,000/μl;
    • Creatinine clearance ≥50 mL/minute, measured using the Cockcroft-Gault formula, and serum creatinine ≤1.5 upper limit of normal (ULN);
    • Alanine aminotransferase (ALT) ≤2.5× ULN, aspartate aminotransferase (AST) ≤2.5×ULN; and total bilirubin ≤1.5×ULN (or ≤3×ULN in cases of Gilbert's syndrome); and
    • International normalized ratio <1.5 and activated partial thromboplastin time (or partial thromboplastin time) within normal limits per the institution.

    Note: Patients on direct-acting anticoagulants or other anticoagulation medications are eligible as long as they are able to hold the drug for the laparoscopic procedure on Day 1 per institutional guidance.

  6. Have evidence of measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan as defined by RECIST v1.1;

    Note: Measurable disease cannot include a lesion that was biopsied. Patients must, at a minimum, have 1 measurable lesion.

    Note: Patients with IP disease who also have disease involving the pleural cavity or distant metastases will be eligible if they have measurable or evaluable disease in the IP cavity.

  7. Are willing and able to provide written informed consent or have a legally authorized representative willing and able to provide informed consent at Screening.

Exclusion Criteria:

  1. Have low-grade serous, mucinous, clear cell, or endometrioid adenocarcinoma of the ovary, primary peritoneum, or fallopian tube; carcinosarcoma; or a mixed histology tumor;
  2. Have another malignancy or have had a prior malignancy within 3 years prior to the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy, excluding adequately managed with curative-intent treatment for basal cell carcinoma, squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, cervical carcinoma in situ, melanoma in situ, or ductal carcinoma in situ of the breast;
  3. Have a known or suspected allergy to AVB-001 or known or suspected allergy to any components of AVB-001, including alginate or seaweed;
  4. Have any condition that, in the opinion of the Investigator, would lead to the inability of the patient to comply with the Protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05538624


Contacts
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Contact: Claudio Dansky Ullmann, MD 508-290-0502 info@avengebio.com

Locations
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United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: Stephanie Canady, RN    240-858-7573    stephanie.canady@nih.gov   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Oladapo Yeku, MD, PhD, FACP    617-724-4000    oyeku@mgh.harvard.edu   
United States, Pennsylvania
UPMC Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Joshua Plassmeyer, MSCR    412-648-6417    plassmeyerjm@upmc.edu   
United States, Rhode Island
Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Emma Locke    401-430-8181    oncologyresearch@wihri.org   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Shannon Westin, MD, MPH    713-794-4314    swestin@mdanderson.org   
Sponsors and Collaborators
Avenge Bio, Inc
Investigators
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Study Director: Claudio Dansky Ullmann, MD Avenge Bio, Inc
More Information
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Responsible Party: Avenge Bio, Inc
ClinicalTrials.gov Identifier: NCT05538624    
Other Study ID Numbers: AVB-1A-101
First Posted: September 14, 2022    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avenge Bio, Inc:
Ovarian Cancer
Primary Peritoneum Cancer
Fallopian Tube Cancer
Immunotherapy
IL-2 Immunotherapy
 Metastatic Cancer
Human Interleukin 2
Interleukin 2
IL-2
Encapsulated Cell Therapy
Additional relevant MeSH terms:
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Adenocarcinoma
Fallopian Tube Neoplasms
Cystadenocarcinoma, Serous
Ovarian Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
 Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders