What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiation therapy and chemoradiation, are associated with several side effects. Radiation therapy can cause mucositis, requiring tube feeding in severe cases, and long-term toxicities like ulceration, soft tissue necrosis, fibrosis, dysphagia, and osteonecrosis. Chemoradiation, which combines chemotherapy with radiation, can exacerbate these side effects and add others like severe skin reactions, hypomagnesemia, and sepsis. The combination of these treatments aims to improve outcomes but often results in significant acute and chronic toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for head and neck cancers that demonstrate tumor reduction and anti-tumor activity. Notably, pembrolizumab, an anti-PD-1 therapy, has shown significant efficacy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), particularly those who have progressed on platinum-based chemotherapy. Cetuximab, an anti-EGFR monoclonal antibody, has also been approved and is often used in combination with platinum-based chemotherapy to improve overall survival and response rates. Additionally, investigational approaches like the combination of pembrolizumab and cetuximab are being explored for their potential synergistic effects in treatment-refractory cases.

What other types of research exist?

Promising novel alternatives to APG-157 for head and neck cancer patients include: 1) MEDI5117, which inhibits IL-6 and decreases cancer stem cells, potentially preventing tumor recurrence. 2) Prim-O-glucosylcimifugin (POG), which enhances the antitumor effect of PD-1 inhibitors by targeting myeloid-derived suppressor cells. Both treatments have shown efficacy in preclinical models and could be considered for further clinical evaluation.

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APG-157 for Head and Neck Cancer

Phase 2

Recruiting

Led By Marilene B Wang, MD

Research Sponsored by Aveta Biomics, Inc.

Eligibility Criteria Checklist

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

Must have

Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients with acceptable TNM staging

Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma

Must not have

Definitive, local treatment available in less than four weeks from initial diagnosis

Bleeding gums or cracked teeth

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation

Awards & highlights

Summary

This trial studies APG-157, a dissolvable lozenge taken orally, in patients with advanced Head & Neck Cancer. The goal is to shrink the tumor before main treatments like surgery to improve patient outcomes.

Who is the study for?

This trial is for newly diagnosed patients with Squamous Cell Carcinoma in the oral cavity or oropharynx. They should be treatment-naive, have no metastatic cancer, and not scheduled for definitive local therapy within four weeks. Excluded are pregnant women, those who've had recent chemotherapy, radiation, or surgery of the mouth, as well as individuals with mental status issues that prevent form completion.

What is being tested?

The trial tests APG-157 as an oral pre-treatment (neoadjuvant) to reduce tumor size before main treatment in head and neck cancer patients. It aims to see if this approach can improve outcomes compared to current standard treatments alone.

What are the potential side effects?

While specific side effects of APG-157 aren't listed here, common ones may include digestive discomforts like nausea or diarrhea; fatigue; possible allergic reactions; and changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have newly diagnosed head and neck cancer that has not been treated yet.

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I have been diagnosed with oral or throat cancer through a biopsy.

Exclusion Criteria

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

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I can start treatment within 4 weeks of my diagnosis.

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I have bleeding gums or cracked teeth.

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My cancer has returned or spread to other parts of my body.

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I have a tooth abscess.

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I had oral, dental, or gum surgery in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Imaging to assess drug's ability to impact tumor size

Secondary study objectives

Biopsy

Cell-free RNA analyses of saliva and blood

Saliva Profile

Trial Design

1Treatment groups

Experimental Treatment

Group I: APG-157Experimental Treatment1 Intervention

Two pastilles (100 mg) taken three times a day (i.e. before meal time).

0 / 7Eligibility 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 Head and Neck Cancers include surgery, radiation therapy, and chemotherapy. Surgery aims to physically remove the tumor, which is crucial for reducing tumor burden. Radiation therapy uses high-energy rays to kill cancer cells by damaging their DNA, which is essential for controlling local and regional disease. Chemotherapy involves the use of drugs to kill rapidly dividing cells, including cancer cells, and can be used alone or in combination with radiation to enhance its effectiveness. APG-157, an investigational treatment, is being studied for its potential to reduce tumor burden through anti-tumor activity, which could improve outcomes by shrinking tumors before definitive therapy. These treatments are vital for Head and Neck Cancer patients as they target the cancer through different mechanisms, increasing the chances of successful management and improving survival rates.

Unraveling the molecular genetics of head and neck cancer through genome-wide approaches.In vitro effect of radiation, antibody to epidermal growth factor receptor and Docetaxel in human head and neck squamous carcinoma cells with mutant P53 and over-expressed EGFR.