APG-157 for Head and Neck Cancer

Not currently recruiting at 1 trial location

Overseen By Marilene B Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aveta Biomics, Inc.

Disqualifiers: Pregnancy, Recent chemotherapy, Metastatic cancer, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

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 APG-157 for individuals with head and neck cancer, specifically in the oral cavity or throat. The goal is to determine if taking APG-157 before any main treatment can shrink tumors and improve outcomes. Participants who may be suitable have newly diagnosed squamous cell carcinoma in these areas and have not yet started other treatments. Eligible participants will take APG-157 as pastilles (lozenges) three times a day before meals. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that APG-157 is likely to be safe for humans?

Research has shown that APG-157 is generally safe for patients with head and neck cancer. In an earlier study, participants experienced no serious side effects from the treatment. While some individuals might have mild side effects, no severe ones were reported. Additionally, the treatment did not delay any subsequent cancer therapy, suggesting it could be a safe option for patients considering this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Unlike the standard care options for head and neck cancer, which often include surgery, radiation, and chemotherapy, APG-157 is a unique treatment derived from natural compounds found in turmeric. Researchers are excited about APG-157 because it has anti-inflammatory and anti-cancer properties that might target cancer cells more directly with fewer side effects. Additionally, APG-157 is administered in the form of a pastille, making it a convenient and non-invasive option compared to traditional therapies. This innovative approach could potentially enhance the effectiveness of treatment while improving the quality of life for patients.

What evidence suggests that APG-157 might be an effective treatment for head and neck cancer?

Research has shown that APG-157, which participants in this trial will receive, might help shrink tumors in patients with head and neck cancer before they begin their main treatment. Studies have found it generally safe, with no serious side effects reported. The FDA granted APG-157 fast track status, indicating its potential. Additionally, combining APG-157 with certain immune therapies might better control tumors. These findings suggest that APG-157 could be a helpful option for reducing cancer before starting standard treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Marilene B Wang, MD

Principal Investigator

VA Los Angeles/UCLA

Elizabeth Franzmann, MD

Principal Investigator

University of Miami Sylvester Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I am scheduled for specific treatments after APG-157, including surgery or radiation for cure or palliation.

Exclusion Criteria

Pregnant women

My doctor considers my mouth or throat condition significant.

I can start treatment within 4 weeks of my diagnosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive APG-157 pastilles three times a day to reduce tumor burden before definitive therapy

4-6 weeks

Daily administration

Definitive Therapy

Participants undergo surgery or other definitive therapy and/or postoperative radiotherapy as determined by the patient's doctor

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• APG-157

Trial Overview 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.

How Is the Trial Designed?

Group I: APG-157 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Aveta Biomics, Inc.

Lead Sponsor

Trials

4

Recruited

90+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6087

Neoadjuvant APG-157 monotherapy in patients with locally ... Results: APG-157 was well tolerated with no treatment-related Grade 3 or 4 adverse events. There was no delay in subsequent definitive therapy.

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05548

Safety and Efficacy of APG-157 in Head and Neck Cancer The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden prior to any definitive therapy to improve the outcomes over current ...

3. cancernetwork.com cancernetwork.com/view/fda-grants-fast-track-status-to-neoadjuvant-apg-157-in-head-and-neck-cancer

FDA Grants Fast Track Status to Neoadjuvant APG-157 in ... Investigators are evaluating the efficacy and safety of APG-157 for patients with head and neck cancer in a phase 2 clinical trial.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38686626/

Enhanced CTLA-4 blockade anti-tumor immunity with APG ... The results indicate that APG-157 and immune checkpoint inhibitor combination treatment could potentially lead to improved tumor control.

5. targetedonc.com targetedonc.com/view/apg-157-earns-fda-fast-track-designation-for-head-and-neck-cancer-treatment

APG-157 Earns FDA Fast Track Designation for Head and ... APG-157 has been granted fast track designation by the FDA for the neoadjuvant treatment of head and neck cancer.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e18119

Preliminary results from a phase IIa trial of APG-157 in oral ... Conclusions: Preliminary pathological and clinical results suggest APG-157 is a well-tolerated and promising treatment for oral and ...