APG-157 for Head and Neck Cancer

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

24 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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.

Research Team

Marilene B Wang, MD

Principal Investigator

VA Los Angeles/UCLA

Elizabeth Franzmann, MD

Principal Investigator

University of Miami Sylvester Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+