AVB-001 for Ovarian Cancer

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

14 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment AVB-001 for ovarian cancer?

The study on VB-111, a similar treatment with anti-cancer properties, showed favorable response rates in patients with platinum-resistant ovarian cancer, suggesting potential effectiveness of treatments with similar mechanisms. ^{1 2 3 4 5}

What safety data exists for AVB-001 (also known as VB-111) in humans?

A study on VB-111, a treatment similar to AVB-001, showed it was used safely in combination with another drug for ovarian cancer, focusing on its ability to target cancer cells and boost the immune system. ^{1 2 5 6 7}

What is the purpose of this trial?

This trial tests AVB-001, a modified cell product that produces IL-2, in patients with difficult-to-treat ovarian, peritoneal, or fallopian tube cancer. The treatment aims to enhance the immune system's ability to fight cancer. Interleukin-2 (IL-2) has been studied for its potential to improve immune function and has shown promise in treating advanced ovarian cancer.

Research Team

Claudio Dansky Ullmann, MD

Principal Investigator

Avenge Bio, Inc

Claudio Dansky Ullman, MD

Principal Investigator

Avenge Bio, Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ofranergene obadenovec (VB-111) in platinum-resistant ovarian cancer; favorable response rates in a phase I/II study are associated with an immunotherapeutic effect. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of nab-paclitaxel and platinum as first-line chemotherapy for ovarian cancer: a retrospective study. [2023]

3. Greece pubmed.ncbi.nlm.nih.gov

Multimodal Treatment of Primary Advanced Ovarian Cancer. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Post hoc analyses of GOG 9923: Does BRCA status affect toxicities?: An NRG oncology study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

nab-Paclitaxel in patients with advanced solid tumors and hepatic dysfunction: a pilot study. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

The potential feasibility of nab-paclitaxel as the first-line chemotherapy for ovarian cancer: clinical development and future perspectives. [2022]