Status:
UNKNOWN
Safety and Efficacy of APG-157 in Head and Neck Cancer
Lead Sponsor:
Aveta Biomics, Inc.
Conditions:
Head and Neck Cancer
Squamous Cell Carcinoma of Oral Cavity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
The patient will receive neoadjuvant therapy (APG-157) during the period between initial diagnosis and time of definitive treatment. APG-157 is an orally administered drug in a form of pastille (soft ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05312710
Start Date
April 22 2022
End Date
December 31 2024
Last Update
August 14 2024
Active Locations (2)
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1
VAGLAHS, West Los Angeles
Los Angeles, California, United States, 90073
2
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136