A Phase 2 interventional study of IPI-549 in Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer and Head and Neck Carcinoma, sponsored by Assuntina G. Sacco, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Assuntina G. Sacco, MD · Phase 2, Interventional, and Treatment
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.
This is a phase 2 window of opportunity trial in patients with locally advanced head and neck cancer. A key objective is to provide the first proof that macrophage phenotype switching can be accomplished in humans and lay the groundwork for future trials of this novel approach to immune therapy. Patients who are candidates for surgical resection will be enrolled and 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.
The study team hypothesizes that mRNA signatures of immune response will be increased in IPI-549-treated patients. For the efficacy endpoints, RECISTv1.1 will be used.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 16 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Assuntina G. Sacco, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days
Drug: IPI-549
40mg by mouth (PO) every day (QD) for at least 14 days
Also known as: Eganelisib
Participants Experiencing Adverse Events
To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.
Time frame: 7 weeks
| Milestone | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Started | 16 |
| Completed | 10 |
| Not completed | 6 |
| Withdrew: Screen failure (did not meet inclusion/exclusion) | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Screen failure (unknown) | 1 |
To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.
| Participants | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Participants Experiencing Adverse Events | 10 |
Collected over 7 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: IPI-549 40 mg PO Qdaily | 0/10 (0%) | 2/10 (20%) | 9/10 (90%) |
| Event | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| SepsisInfections and infestations | 1/10 |
| Oral hemorrhageGastrointestinal disorders | 1/10 |
| Event | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Gastrointestinal disordersGastrointestinal disorders | 8/10 |
| General disorders and administration site conditionsGeneral disorders | 4/10 |
| Nervous system disordersNervous system disorders | 3/10 |
| Immune system disordersImmune system disorders | 1/10 |
| InvestigationsInvestigations | 1/10 |
| Psychiatric disordersPsychiatric disorders | 1/10 |
| Renal and urinary disordersRenal and urinary disorders | 1/10 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 1/10 |
| Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders | 1/10 |
| Vascular disordersVascular disorders | 1/10 |
| Age, Categorical(Participants) | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 3 |
| Age, Continuous(Years) | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Mean | 56.2 ± 13.29 |
| Sex: Female, Male(Participants) | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Female | 3 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 1 |
| Unknown or Not Reported | 2 |
| Cancer Type(Participants) | Arm A: IPI-549 40 mg PO Qdaily |
|---|---|
| Nasal cavity | 1 |
| Oral cavity | 4 |
| Oropharynx | 5 |
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Squamous Cell Carcinoma of Head and Neck→
Assuntina G. Sacco, MD