APG-157 for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMarilene B Wang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Aveta Biomics, Inc.

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

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.

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.

+7 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: APG-157Experimental Treatment1 Intervention

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