Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.

Patients will be treated with 3 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ezra Cohen
• Collaborator: The V Foundation for Cancer Research

Criteria

Inclusion Criteria:

• Have locally advanced that is amenable to surgical resection

• Must be able to swallow tablets

• Must be able to undergo a core tumor biopsy.

• Must have adequate organ function.

Exclusion Criteria:

• Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer.

• Planned major surgery within 4 weeks prior to initiation of study drug

• Patients treated with chemotherapy, biologic therapy, or other investigational agent within < 28 days of starting study drug

• History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus (HCV)

• On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids

• Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g. gastric bypass surgery, gastrectomy)

• Female subjects who are pregnant or breastfeeding

• Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia