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Cell Therapy

AVB-001 for Ovarian Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Avenge Bio, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year (part 1); 1 year (part 2)
Awards & highlights

Study Summary

This trial evaluates a new treatment (AVB-001) for ovarian cancer, which is delivered IP to patients. It tests safety and efficacy of a single dose.

Who is the study for?
This trial is for patients with high-grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube that's resistant to platinum-based chemotherapy. They must have measurable disease and can't have had more than five prior therapies. Those with certain gene mutations need to have progressed after PARP inhibitor therapy.Check my eligibility
What is being tested?
The study tests AVB-001, a cell product designed to produce interleukin-2 for treating ovarian cancer. It's given directly into the abdominal cavity in two phases: dose escalation and expansion, aiming to assess its safety and effectiveness.See study design
What are the potential side effects?
While specific side effects are not listed here, common reactions may include immune system responses due to interleukin-2 production such as fever, fatigue, nausea; local reactions at the injection site; or allergic reactions if sensitive to components like alginate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had 5 or fewer previous cancer treatments.
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I may have had treatments like immunotherapy or targeted therapy for my cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type that started in the ovary, peritoneum, or fallopian tube and cannot be removed or treated with platinum-based chemotherapy.
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I can give or have someone who can give consent for me.
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I can stop my blood thinner medication for surgery if needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year (part 1); 1 year (part 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (part 1); 1 year (part 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs) of IP administered AVB-001 to determine the MTD and RP2D in the Dose Escalation Phase (Part 1)
Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs) of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
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)
Secondary outcome measures
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Escalation Phase (Part 1)
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Expansion Phase (Part 2)
DOR in the Dose Expansion Phase (Part 2)
+9 more
Other outcome measures
Analysis of anti-drug antibodies (ADA) to AVB-001 in human serum in the Dose Escalation and Dose Expansion Phases (Parts 1 and 2)
Immunologic changes in peripheral blood and IP environments in the Dose Escalation and Dose Expansion Phases (Parts 1 and 2)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Part 1 escalating AVB-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 AVB-001 at the MTD/RP2DExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Avenge Bio, IncLead Sponsor
Claudio Dansky Ullmann, MDStudy DirectorAvenge Bio, Inc
1 Previous Clinical Trials
14 Total Patients Enrolled
Claudio Dansky Ullman, MDStudy DirectorAvenge Bio, Inc

Media Library

AVB-001 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05538624 — Phase 1 & 2
Serous Carcinoma Research Study Groups: 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
Serous Carcinoma Clinical Trial 2023: AVB-001 Highlights & Side Effects. Trial Name: NCT05538624 — Phase 1 & 2
AVB-001 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538624 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants eligible for this scientific experiment?

"Affirmative. According to the clinicaltrials.gov database, this trial is currently recruiting volunteers. It was first posted on November 1st 2022 and recently updated on November 22nd 2022; 44 people are needed from one site for full participation in the study."

Answered by AI

Are individuals still able to join this ongoing experiment?

"Affirmative, clinicaltrials.gov confirms that this trial is actively enrolling patients. It was first publicized on November 1st 2022 and has undergone recent edits as of the 22nd of November in said year. A total of 44 participants are being recruited for a single location."

Answered by AI

Who else is applying?

What site did they apply to?
National Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
~29 spots leftby Aug 2026