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PI3K-gamma Inhibitor

IPI-549 (eganelisib) for Adrenocortical Cancer

Phase 1
Waitlist Available
Research Sponsored by Infinity Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up responses assessed in cycle 3 and every odd cycle through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will study the effects of a new drug, IPI-549, on patients with advanced solid tumors. The investigators will evaluate how well the drug is tolerated and how it affects the body.

Eligible Conditions
  • Adrenocortical Cancer
  • Mesothelioma
  • Breast Cancer
  • Squamous Cell Carcinoma
  • Melanoma
  • Myeloid-Derived Suppressor Cells
  • Solid Tumors
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~responses assessed in cycle 3 and every odd cycle through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and responses assessed in cycle 3 and every odd cycle through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A/B/C: Dose Limiting Toxicities (DLT)
Part D/E: Adverse Events (AE) and safety laboratory values
Secondary outcome measures
Part A/B: Adverse Events (AE) and safety laboratory values
Part A/B: Duration of response (DoR)
Heart rate
+25 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: Part H: High-circulating MDSCs: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with high-circulating MDSCs receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group II: Part G: Mesothelioma: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with mesothelioma receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group III: Part G: ACC: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with adrenocortical carcinoma receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group IV: Part F: TNBC: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with triple negative breast cancer receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group V: Part E: SCCHN: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with squamous cell cancer of the head and neck receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group VI: Part E: NSCLC: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with NSCLC receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group VII: Part E: Melanoma: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants with melanoma receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group VIII: Part D: IPI-549 MonotherapyExperimental Treatment1 Intervention
Participants receive IPI-549 (dose determined from Part A/B) orally until disease progression.
Group IX: Part D Annex: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group X: Part C: IPI-549 and nivolumabExperimental Treatment2 Interventions
Participants receive IPI-549 (dose determined from Part A/B) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
Group XI: Part A/B: IPI-549 Dose EscalationExperimental Treatment1 Intervention
Participants receive IPI-549 orally (PO) once a day (QD) for Part A and twice a day (BID) in Part B until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IPI-549 (eganelisib)
2019
Completed Phase 2
~50
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Infinity Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
1,247 Total Patients Enrolled
Feng Chi, MDStudy DirectorInfinity Pharmaceutical, Inc.
Halle Zhang, PhD, RNStudy DirectorInfinity Pharmaceutical, Inc.
2 Previous Clinical Trials
140 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549
2015. "A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02637531.
~23 spots leftby Apr 2025
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