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

Description

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

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

Study Overview

Study Details

Study overview

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.

Phase 2 Study to Evaluate the Safety and Efficacy of APG-157 as Neoadjuvant/Induction Therapy for Patients With Head and Neck Squamous Cell Cancer (HNSCC) of the Oral Cavity and/or Oropharynx

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

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

VAGLAHS, West Los Angeles, Los Angeles, California, United States, 90073

Miami

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Local Therapy with Curative Intent Surgery alone or surgery followed by radiation.
  • 2. 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.
  • 3. Patients who refuse surgery or are unfit for any local therapy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aveta Biomics, Inc.,

Marilene B Wang, MD, PRINCIPAL_INVESTIGATOR, VA Los Angeles/UCLA

Elizabeth Franzmann, MD, PRINCIPAL_INVESTIGATOR, University of Miami Sylvester Comprehensive Cancer Center

Study Record Dates

2024-12-31