A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIPI-549 (eganelisib) and Nivolumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 4, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?11 U.S. locations

Locations may change over time.

Who runs it?Infinity Pharmaceuticals, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Infinity Pharmaceuticals, Inc.
Interventions being studied: Drug: IPI-549 (eganelisib); Drug: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Mesothelioma→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

All subjects must meet the following criteria for inclusion:
≥ 18 years of age
Life expectancy of ≥ 3 months
Histological or cytological evidence of advanced and/or metastatic carcinoma or melanoma , excluding sarcoma
At least 1 measurable disease lesion as defined by RECIST 1.1
Serum creatinine clearance ≥ 60 mL/min and serum creatinine ≤ 2.0 x the upper limit of normal (ULN) as determined by either of the following: Estimation as calculated by Cockcroft-Gault equation or Direct measurement by 24-hour urine collection
Total bilirubin ≤ 1.5 x ULN (unless elevated due to Gilbert's syndrome)
Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 x ULN (\<5x ULN if liver metastasis)
Adequate hematological function, defined as absolute neutrophil count ≥1.5 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (corresponds to Karnofsky Performance Status (KPS) ≥ 60%) Subjects entering Part A, B, C, or D must also meet the following additional criterion:
Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgement of the Investigator) Subjects entering Part D, E, F or G must also meet the following additional criterion:
Willing to undergo 1 pre-treatment and 1 on-treatment tumor biopsy Subjects entering Part E must also meet the following additional criteria:
Histological or cytological evidence of NSCLC, melanoma, , human papillomavirus (HPV) positive or HPV negative SCCHN (oral cavity, pharynx, hypopharynx, larynx, nasopharyngeal \[including undifferentiated nasopharyngeal carcinoma\]), or another tumor type to be determined
Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the Investigator The most recent treatment prior to study entry must be an anti-PD-1 or anti-PD-L1 antibody given as either monotherapy or in combination
Subjects with NSCLC Tumors that harbor an actionable genetic alteration for which there is a corresponding approved therapy for that specific alteration (including but not limited to alterations in EGFR, ALK, and ROS) must have progressed on, or had intolerance to, the respective therapy Subjects entering Part F must also meet the following additional criteria:
Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue; or another tumor type to be determined
ER/PgR negativity to follow local guidelines
If IHC HER2 2+, a negative FISH test is required
Inflammatory triple negative breast cancer is allowed
Must have received and failed/progressed a cytotoxic chemotherapy as first line therapy per standard of care
No prior anti-PD-1 or anti-PD-L1 therapy Subjects entering Part G must also meet the following additional criteria:
Histological or cytological evidence of ACC, mesothelioma, or another tumor type to be determined
Both pleural and peritoneal mesothelioma are allowed
Epithelioid, sarcomatoid, or biphasic mesothelioma subtypes are allowed
Progression after at least first line available therapy Patients entering Part H must also meet the following additional criteria: High-circulating MDSCs, currently defined for this study as MDSCs ≥ 20.5% as measured by CLIA-certified Serametrix assay Microsatellite status of tumor has been determined Patients with tumors that are microsatellite instability-high must have previously received an anti-PD-1/anti-PD-L1 therapy and progressed on therapy If patient's tumor type is one for which anti-PD-1/anti-PD-L1 therapy is standard of care, patient must have previously received an anti-PD-1 or anti-PD-L1 therapy and progressed while on that therapy

Reasons someone may not be able to joinExclusion criteria

Subjects are to be excluded from the study if they meet any of the following criteria:
Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any excipient in the study drugs
Major surgery within 4 weeks prior to Screening
Subjects who have been treated with chemotherapy, biologic therapy, or other investigational agent within \< 5 times the half-life of the agent or \< 28 days (whichever is shorter) of starting study drug NOTE: Subjects whose immediate prior treatment was with nivolumab may start study drug 2 weeks after the last dose of nivolumab
Symptomatic or untreated brain metastases
Primary central nervous system (CNS) malignancy
Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids
Ongoing systemic bacterial, fungal, or viral infections at Screening NOTE: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

UCSDSan Diego, California
UCLASanta Monica, California
Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
Emory UniversityAtlanta, Georgia
Massachusetts General HospitalBoston, Massachusetts
Beth Israel Deaconess Medical CenterBoston, Massachusetts
Dana-Farber Cancer InstituteBoston, Massachusetts
Hackensack University Medical CenterHackensack, New Jersey
Memorial Sloan Kettering Cancer CenterNew York, New York
MD Anderson Cancer CenterHouston, Texas
South Texas Accelerated Research and Treatment (START)San Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 4, 2022. Always confirm current availability with the study team.

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