ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2022-04-22
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05312710

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Local Therapy with Curative Intent Surgery alone or surgery followed by radiation.
  2. 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. 3. Patients who refuse surgery or are unfit for any local therapy.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Marilene B Wang, MD
PRINCIPAL_INVESTIGATOR
VA Los Angeles/UCLA
Elizabeth Franzmann, MD
PRINCIPAL_INVESTIGATOR
University of Miami Sylvester Comprehensive Cancer Center

Study Locations (Sites)

VAGLAHS, West Los Angeles
Los Angeles, California, 90073
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-22
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-04-22
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Neoadjuvant
  • Induction Therapy
  • Oral Cancer
  • Oropharyngeal Cancer

Additional Relevant MeSH Terms

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