- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Claudio Dansky Ullmann, MD
- Phone Number: 508-290-0502
- Email: info@avengebio.com
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC Magee-Womens Hospital
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Women & Infants Hospital of Rhode Island
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
- Have not received more than 5 lines of prior therapy;
- 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);
- Have an Eastern Cooperative Oncology Group performance status 0 to 1 at Screening;
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.
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.
- 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:
- Have low-grade serous, mucinous, clear cell, or endometrioid adenocarcinoma of the ovary, primary peritoneum, or fallopian tube; carcinosarcoma; or a mixed histology tumor;
- 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;
- Have a known or suspected allergy to AVB-001 or known or suspected allergy to any components of AVB-001, including alginate or seaweed;
- Have any condition that, in the opinion of the Investigator, would lead to the inability of the patient to comply with the Protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Investigator-assessed ORR per RECIST v1.1 of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
Time Frame: 1 year
|
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
|
1 year
|
Duration of response (DOR) in the Dose Escalation Phase (Part 1)
Time Frame: 1 year
|
1 year
|
Progression Free Survival (PFS) in the Dose Escalation Phase (Part 1)
Time Frame: 1 year
|
1 year
|
Overall survival (OS) in the Dose Escalation Phase (Part 1)
Time Frame: 1 year
|
1 year
|
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Escalation Phase (Part 1)
Time Frame: 1 year
|
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
|
1 year
|
Investigator-assessed ORR per iRECIST of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
Time Frame: 1 year
|
1 year
|
DOR in the Dose Expansion Phase (Part 2)
Time Frame: 1 year
|
1 year
|
PFS in the Dose Expansion Phase (Part 2)
Time Frame: 1 year
|
1 year
|
OS in the Dose Expansion Phase (Part 2)
Time Frame: 1 year
|
1 year
|
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Expansion Phase (Part 2)
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
1 year (Part 1); 1 year (Part 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)
|
1 year (Part 1); 1 year (Part 2)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Claudio Dansky Ullmann, MD, Avenge Bio, Inc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Cystadenocarcinoma
- Neoplasms, Cystic, Mucinous, and Serous
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Adenocarcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Cystadenocarcinoma, Serous
Other Study ID Numbers
- AVB-1A-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fallopian Tube Cancer
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
OncoMed Pharmaceuticals, Inc.CompletedCancer Ovaries | Cancer Peritoneal | Cancer, Fallopian TubeUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...Istituto Di Ricerche Farmacologiche Mario Negri; Foundation MedicineRecruitingAdvanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube CancerItaly
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Stage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage I Ovarian Cancer AJCC v6 and v7 | Stage IA Fallopian Tube Cancer AJCC v6 and v7 | Stage IB Fallopian Tube Cancer AJCC v6 and v7 | Stage IC Fallopian Tube Cancer AJCC v6 and v7 | Stage II Ovarian Cancer AJCC v6 and v7 | Stage IIA Fallopian Tube Cancer AJCC v6 and v7 | Stage IIB Fallopian... and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterGenentech, Inc.CompletedOvarian Cancer | Peritoneal Cancer | Fallopian Tubes CancerUnited States
-
Genentech, Inc.CompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal CancerUnited States
-
Precision TherapeuticsCompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal CancerUnited States
-
Centre Jean PerrinCompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cavity CancerFrance
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Sanofi Pasteur, a Sanofi CompanyCompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditionsUnited States
Clinical Trials on AVB-001 (Dose Escalation Phase)
-
Benitec Biopharma, Inc.RecruitingOculopharyngeal Muscular DystrophyUnited States
-
AtlasMedx, IncorporatedActive, not recruitingBreast Cancer | Pancreatic Cancer | Ovarian Cancer | Prostate Cancer | Homologous Recombination Deficiency | Advanced Malignant NeoplasmUnited States
-
Domain Therapeutics SARecruitingSolid Tumor, AdultFrance, Belgium
-
RasCal Therapeutics, Inc.RecruitingGlioblastoma | Pancreatic Cancer | Lung Cancer | Colon Cancer | Advanced Malignant Solid Neoplasm | RAS MutationUnited States
-
Shanghai Hansoh Biomedical Co., LtdRecruiting
-
Shanghai Hansoh Biomedical Co., LtdRecruitingAdvanced Solid TumorChina
-
Tyligand Bioscience (Shanghai) LimitedRecruitingHas a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or LymphomaChina
-
Pierre Fabre MedicamentActive, not recruitingAdvanced or Metastatic Solid TumorsFrance, Spain
-
Millennium Pharmaceuticals, Inc.Completed