What side effects are associated with this type of intervention?

Common side effects of targeted therapies and immunotherapies for solid tumors include fatigue, skin reactions (such as rash and pruritus), gastrointestinal issues (such as diarrhea and nausea), and infusion-related reactions. More specific side effects can include hypertension, stomatitis, and neutropenia. These treatments can also lead to immune-related adverse events, such as pneumonitis, colitis, hepatitis, and endocrinopathies, which may require management with immunosuppressive agents like steroids.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of solid tumors. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and have been approved for various solid tumors such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, drugs like atezolizumab, targeting PD-L1, and bevacizumab, an anti-VEGF monoclonal antibody, have been approved for use in combination therapies for cancers like hepatocellular carcinoma. These treatments, similar to ALG.APV-527, leverage the body's immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to ALG.APV-527 for solid tumor patients include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer (NSCLC) as per the KEYNOTE-189 trial. 2) Avelumab, a PD-L1 inhibitor, which has shown durable responses in mesothelioma patients in the JAVELIN trial. 3) Atezolizumab combined with bevacizumab, which has demonstrated efficacy in renal cell carcinoma with sarcomatoid features in the IMmotion151 trial. 4) Anti-CD137 (4-1BB) monoclonal antibodies, which are in clinical trials for various cancers and have shown a favorable toxicity profile.

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Cancer Vaccine

ALG.APV-527 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Aptevo Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of both dose escalation and dose expansion ( approx 42 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ALG.APV-527, in adults with advanced solid tumors who have no other effective treatments. The drug is given through an IV to find the safest dose. Researchers aim to see if the drug is safe and can help shrink tumors.

Who is the study for?

Adults with advanced solid tumors that have failed standard treatments or for whom no effective therapy exists. They must be over 18, have a life expectancy of at least 3 months, and agree to use effective birth control. Specific cancers include NSCLC, breast cancer, ovarian cancer among others. Participants need adequate organ function and measurable lesions by CT/MRI.

What is being tested?

The trial is testing ALG.APV-527 in patients with advanced solid tumors likely to express the 5T4 antigen. It's an open-label study with two parts: dose escalation (about 36 patients) and dose expansion (about 20 patients), focusing on safety and optimal dosing.

What are the potential side effects?

As this is a first-in-human study for ALG.APV-527, specific side effects are not yet known but may include typical reactions related to immune therapies such as fatigue, infusion-related reactions, autoimmune-like symptoms or exacerbation of underlying conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of both dose escalation and dose expansion ( approx 42 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of both dose escalation and dose expansion ( approx 42 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of both dose escalation and dose expansion ( approx 42 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with dose-limiting toxicities (DLTs)

Overall Response Rate

Secondary study objectives

Pharmacokinetic measure- Area under the plasma concentration versus time curve (AUC)

Pharmacokinetic measure- Peak Plasma Concentration (Cmax)

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: ALG.APV-527Experimental Treatment1 Intervention

Part 1 Dose Escalation using ALG.APV-527 doses with a starting dose of 0.1 mg/kg and projected 6 dose cohorts will be explored to determine the MTD and/or the RP2D. Part 1 consists of a 3 + 3 dose-escalation examination of ALG.APV-527 single agent therapy in adult patients with RECIST Version1.1-measurable advanced solid tumors. Part 2 Dose Expansion with ALG.APV-527 based on RP2D determined during Dose Escalation.

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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

Common treatments for solid tumors, particularly targeted therapies and immunotherapies, work by identifying and attacking specific antigens or proteins expressed on cancer cells. For example, ALG.APV-527 targets the 5T4 antigen, which is often present on advanced solid tumors. These therapies enhance the immune system's ability to recognize and destroy cancer cells while minimizing damage to normal cells. This targeted approach is crucial for patients with solid tumors as it offers a more effective and less toxic treatment option compared to traditional chemotherapy, potentially leading to better outcomes and improved quality of life.

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