CLINICAL TRIALS PROFILE FOR IPI-549

Clinical Trials for IPI-549

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02637531 ↗	A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549	Active, not recruiting	Infinity Pharmaceuticals, Inc.	Phase 1	This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.
NCT03719326 ↗	A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies	Completed	Infinity Pharmaceuticals, Inc.	Phase 1	This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.
NCT03719326 ↗	A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies	Completed	Arcus Biosciences, Inc.	Phase 1	This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.
NCT03795610 ↗	Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma	Recruiting	The V Foundation for Cancer Research	Phase 2	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.

Clinical Trial Conditions for IPI-549

Condition Name

Condition Name
Intervention	Trials
HPV-Related Squamous Cell Carcinoma	1
Bladder Cancer	1
Melanoma (Part E)	1
Breast Cancer	1

Condition MeSH

Condition MeSH
Intervention	Trials
Carcinoma	3
Triple Negative Breast Neoplasms	3
Head and Neck Neoplasms	2
Breast Neoplasms	2

Clinical Trial Locations for IPI-549

Trials by Country

Trials by Country
Location	Trials
United States	41
Australia	3
France	1
Serbia	1
Czechia	1

Trials by US State

Trials by US State
Location	Trials
California	4
Florida	3
Maryland	3
Texas	3
Tennessee	2

Clinical Trial Progress for IPI-549

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Active, not recruiting	2
Recruiting	2
Completed	1

Clinical Trial Sponsors for IPI-549

Sponsor Name

Sponsor Name
Sponsor	Trials
Infinity Pharmaceuticals, Inc.	4
Arcus Biosciences, Inc.	1
The V Foundation for Cancer Research	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	7
Other	2