What side effects are associated with this type of intervention?

Common treatments for serous carcinoma, particularly those involving interleukin-2 (IL-2) like AVB-001, often include immunotherapy. Known side effects of IL-2-based treatments can include flu-like symptoms (fever, chills, fatigue), gastrointestinal issues (nausea, vomiting, diarrhea), and more severe effects such as capillary leak syndrome, which can lead to low blood pressure and organ dysfunction. Additionally, patients may experience skin reactions, increased risk of infections, and changes in blood cell counts.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Serous Carcinoma involving encapsulated cells producing native human interleukin-2 (hIL-2) similar to AVB-001. However, immunotherapy approaches, including the use of interleukin-2, have been explored in various cancers. For Serous Carcinoma, treatment typically involves a combination of surgery, chemotherapy, and targeted therapies. The development of novel treatments like AVB-001 represents ongoing research efforts to improve outcomes for patients with this type of cancer.

What other types of research exist?

Promising novel alternatives to AVB-001 for Serous Carcinoma patients include: 1) Streptavidin-tagged human IL-2 (SA-hIL-2) immobilized on the biotinylated mucosal surface, which has shown efficacy in a mouse model of bladder cancer. 2) H2Mab-41, an anti-HER2 monoclonal antibody, which has demonstrated antitumor activities in mouse xenograft models. 3) Oncolytic Herpes Simplex Virus Type 2 expressing a bispecific antibody, which has shown enhanced therapeutic effects against solid tumors. These alternatives leverage advanced immunotherapy and targeted approaches that could be beneficial for Serous Carcinoma patients.

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Cell Therapy

AVB-001 for Ovarian Cancer

Phase 1 & 2

Waitlist Available

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

Have an Eastern Cooperative Oncology Group performance status 0 to 1 at Screening

Must not have

Have low-grade serous, mucinous, clear cell, or endometrioid adenocarcinoma of the ovary, primary peritoneum, or fallopian tube; carcinosarcoma; or a mixed histology tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is a specific type affecting the ovary, peritoneum, or fallopian tube.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Serous Carcinoma, particularly those similar to AVB-001, involve immunotherapy approaches such as the use of interleukin-2 (IL-2). IL-2 is a cytokine that plays a crucial role in the activation and proliferation of T-cells and natural killer (NK) cells, which are essential for the immune system's ability to target and destroy cancer cells. Encapsulated cell products like AVB-001 are engineered to produce native human IL-2, which is delivered directly to the tumor site, enhancing the local immune response against the cancer. This targeted approach is significant for Serous Carcinoma patients as it aims to boost the body's natural defenses specifically where they are needed most, potentially improving treatment efficacy and reducing systemic side effects.

Immunotherapy with interleukin-2 (IL2) and lymphokine-activated natural killer cells: improvement of clinical responses in metastatic renal cell carcinoma patients previously treated with IL2.Radiation therapy and immunotherapy-a potential combination in cancer treatment.Immunologic approaches to ovarian cancer treatment.