AVB-001 for Ovarian Cancer

No longer recruiting at 4 trial locations

Overseen By Claudio Dansky Ullmann, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Avenge Bio, Inc

Disqualifiers: Low-grade serous, other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AVB-001 for ovarian cancer. The goal is to assess its safety and effectiveness when given as a single dose to patients with certain types of advanced ovarian cancer that have not responded well to other treatments. The study targets a specific group: those with high-grade serous adenocarcinoma of the ovary or similar cancers who have frequently relapsed after platinum-based chemotherapy. Participants should also have measurable disease visible on scans like CT or MRI. As a Phase 1 trial, this research aims to understand how AVB-001 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation medications, you must be able to pause them for the laparoscopic procedure on Day 1.

Is there any evidence suggesting that AVB-001 is likely to be safe for humans?

Research has shown that AVB-001 appears safe based on earlier studies. In animal tests, AVB-001 did not cause harm and effectively targeted tumors.

Additionally, in the first group of patients from an earlier part of this trial, AVB-001 was well-tolerated, with no major side effects reported. This suggests the treatment might be safe for humans, but further testing is necessary to confirm this.

In summary, while early results are promising, ongoing studies are essential to fully understand the safety of AVB-001 for treating ovarian cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Unlike the standard of care for ovarian cancer, which often involves chemotherapy and surgery, AVB-001 introduces a novel approach by harnessing a unique mechanism of action. AVB-001 is an experimental treatment that uses human interleukin-2 (hIL-2) to potentially enhance the body's immune response against cancer cells. Researchers are excited because this immune-modulating strategy could offer a more targeted way to combat ovarian cancer, possibly with fewer side effects than traditional chemotherapy. Additionally, the dose-escalation and expansion phases aim to pinpoint the optimal dose, maximizing effectiveness while minimizing risks.

What evidence suggests that AVB-001 might be an effective treatment for ovarian cancer?

Research has shown that AVB-001 could aid in treating ovarian cancer. In animal studies, AVB-001 slowed tumor growth and extended survival. This treatment delivers a large amount of interleukin-2 (IL-2), a protein that helps the immune system combat cancer cells. The FDA recognized AVB-001's potential by granting it fast track designation, a special status for treatments that could address significant medical needs. These findings suggest AVB-001 might offer a new option for patients with difficult-to-treat ovarian cancer. Participants in this trial will receive AVB-001 in varying doses to determine the most effective and safe dosage. ^{1 3 5 6 7}

Who Is on the Research Team?

Claudio Dansky Ullmann, MD

Principal Investigator

Avenge Bio, Inc

Claudio Dansky Ullman, MD

Principal Investigator

Avenge Bio, Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had 5 or fewer previous cancer treatments.

My cancer is a type that started in the ovary, peritoneum, or fallopian tube and cannot be removed or treated with platinum-based chemotherapy.

I may have had treatments like immunotherapy or targeted therapy for my cancer.

Exclusion Criteria

I haven't had cancer, except for certain skin, cervical, or breast conditions, in the last 3 years.

You are allergic to AVB-001 or any of its ingredients, like 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1: Dose Escalation Phase using a Bayesian optimal interval model-assisted design to determine the maximally tolerated dose of AVB-001

Not specified

Dose Expansion

Part 2: Dose Expansion Phase where a single dose of AVB-001 at the recommended Phase 2 dose is administered to additional patients

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AVB-001

Trial Overview 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.

How Is the Trial Designed?

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/RP2D Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Avenge Bio, Inc

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

In a study of 424 women with epithelial ovarian cancer, those with BRCA-associated tumors tolerated chemotherapy regimens similarly to those without BRCA mutations, showing no significant differences in toxicity rates such as anemia and nausea.

Despite the known chemosensitivity benefits of BRCA mutations, the median progression-free survival was not significantly different between BRCA-associated and wild type tumors, indicating that BRCA status may not influence treatment outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post hoc analyses of GOG 9923: Does BRCA status affect toxicities?: An NRG oncology study. Gillen, J., Miller, A., Bell-McGuinn, KM., et al.[2022]

Optimal surgical debulking to achieve no residual disease (R0) significantly improves survival rates in patients with epithelial ovarian cancer, which is crucial given its high mortality rate.

The SOLO-1 trial demonstrated that olaparib, a maintenance therapy, significantly reduces the risk of disease progression by 70% in patients with advanced ovarian cancer who have BRCA mutations, highlighting its efficacy in targeted treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Treatment of Primary Advanced Ovarian Cancer. Friedrich, M., Friedrich, D., Kraft, C., et al.[2021]

Angiogenesis inhibitors significantly improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in patients with recurrent ovarian cancer, based on a review of 13 studies involving 3953 patients.

However, these treatments are associated with a higher risk of severe adverse events (grade ≥ 3), indicating a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of angiogenesis inhibitors for recurrent ovarian cancer: a meta‑analysis. Zhang, C., Zhao, W.[2022]

Citations

1. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(23)00978-2/fulltext

Favorable preclinical efficacy and safety profile of AVB-001 ... Preclinical studies demonstrate AVB-001 is dose adjustable, safe, and efficacious in multiple animal models and create a high locoregional concentration of IL-2 ...

2. targetedonc.com targetedonc.com/view/fda-fast-tracks-avb-001-for-relapsed-refractory-ovarian-cancer

FDA Fast Tracks AVB-001 for Relapsed/Refractory Ovarian ... The FDA has granted an FTD to AVB-001 as a treatment option for adult patients with relapsed/refractory ovarian cancer.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5616

A phase 1/2 open-label, multicenter, dose escalation and ... IP AVB-001 inhibited tumor growth and improved survival in an in vivo ID8 ovarian cancer murine model. Sustained IL-2 production with well ...

4. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A1137

1094 Favorable preclinical efficacy and safety profile of ... Conclusions It was demonstrated that the AVB-001 is dose adjustable, safe and efficacious in preclinical animal models. Avenge Bio aims to ...

5. cancernetwork.com cancernetwork.com/view/avb-001-receives-fda-ftd-in-platinum-resistant-ovarian-cancer

AVB-001 Receives FDA FTD in Platinum-Resistant ... The FDA has granted fast track designation to the investigational AVB-001 as a therapy for patients with platinum-resistant relapsed/refractory ovarian cancer.

6. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A1135

Main menu Conclusions It was demonstrated that the AVB-001 is dose adjustable, safe and efficacious in preclinical animal models. Avenge Bio aims to pursue a Phase 1 ...

7. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(23)00978-2/pdf

Favorable preclinical efficacy and safety profile of AVB-001 ... Treatment of solid tumors using a single administration of AVB-001 demonstrated complete response as monotherapy and provided sustained eradication of ...