Safety and Efficacy of APG-157 in Head and Neck Cancer

NCT05312710 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AVTA 20-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head \& Neck Cancer of oral cavity and/or oropharynx. 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 standard of care.

Conditions

Squamous Cell Carcinoma of Oral Cavity; Squamous Cell Carcinoma of the Oropharynx; Head and Neck Cancer

Keywords

Neoadjuvant; Induction Therapy; Oral Cancer; Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Imaging to assess drug's ability to impact tumor size

  Change in Tumor Size from Baseline to end of dosing using MRI with or without contrast and PET/CT imaging.

  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

Secondary Outcomes (3)

• Biopsy

  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

• Saliva Profile

  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

• Cell-free RNA analyses of saliva and blood

  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

Study Arms (1)

APG-157

EXPERIMENTAL

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

Drug: APG-157

Interventions

APG-157 DRUG

Treatment

APG-157

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma.
• B. Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients. Staging is done according to the International Union Against Cancer's (UICC) classification system for oral cancer. Acceptable TNM staging is T1-4, N0-2, M0.
• C. Patients who are scheduled to receive the following therapy after APG-157 treatment.
• Local Therapy with Curative Intent Surgery alone or surgery followed by radiation.
• Therapy with Palliative Intent Radiation alone. Radiation with concurrent radiosensitizing chemotherapeutic agents only using QUAD-shot protocol. Radiosensitizing chemotherapeutic agents are limited to carboplatin or cetuximab.
• Patients who refuse surgery or are unfit for any local therapy.

You may not qualify if:

• A. Patients whose definitive, local treatment is available in less than four weeks from initial diagnosis. For example, some patients who are scheduled to receive chemo-radiation therapy as the local therapy with curative intent.
• B. Pregnant women.
• C. Prior Chemotherapy or radiation therapy within the last 8 weeks.
• D. Patients with recurrent or metastatic cancer.
• E. Tooth abscesses.
• F. Bleeding gums or cracked teeth.
• G. Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks.
• H. Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks.
• I. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
• J. Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.

Sponsors & Collaborators

• Aveta Biomics, Inc.: lead

Study Sites (2)

VAGLAHS, West Los Angeles

Los Angeles, California, 90073, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Marilene B Wang, MD

  VA Los Angeles/UCLA

  PRINCIPAL INVESTIGATOR

• Elizabeth Franzmann, MD

  University of Miami Sylvester Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 5, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)