Phase 2
N=16
IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma · Head and Neck Cancer · Head and Neck Carcinoma · Head and Neck Cancer Stage IV · Head and Neck Cancer Stage III
Bottom Line
View on ClinicalTrials.gov: NCT03795610 ↗Enrolled (actual)
16
Serious AEs
20.0%
Results posted
Jul 2025
Primary outcome: Primary: Participants Experiencing Adverse Events — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IPI-549 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Assuntina G. Sacco, MD
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Experiencing Adverse Events |
10 | — |
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 2 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03795610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.