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

Conditions

• Adrenocortical Carcinoma (Part G)
• Advanced Solid Tumors (Part A/B/C/D)
• High-circulating Myeloid-derived Suppressor Cells (Part H)
• Melanoma (Part E)
• Mesothelioma (Part G)
• Non-small Cell Lung Cancer (Part E)
• Squamous Cell Cancer of the Head and Neck (Part E)
• Triple Negative Breast Cancer (Part F)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IPI-549 (eganelisib) — DRUG
  IPI-549 daily dose administered orally in 28-day cycles (Part A/BC/D/D-Annex/E)
• Nivolumab — DRUG
  Nivolumab (240 mg, Q2W) administered intravenously (IV) in 28-day cycles (Part C/D-Annex/E).

Study Details

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.

Key Dates

Start date

Dec 31, 2015

Status verified

Apr 2022

Primary completion

Jan 31, 2022

Completion

Dec 31, 2022

Study Design

Enrollment

219 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Part A/B: IPI-549 Dose Escalation
  Participants receive IPI-549 orally (PO) once a day (QD) for Part A and twice a day (BID) in Part B until disease progression.
• Experimental: Part C: IPI-549 and nivolumab
  Participants receive IPI-549 (dose determined from Part A/B) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
• Experimental: Part D: IPI-549 Monotherapy
  Participants receive IPI-549 (dose determined from Part A/B) orally until disease progression.
• Experimental: Part D Annex: IPI-549 and nivolumab
  Participants receive IPI-549 (dose determined from Part A/B/C) orally in combination with nivolumab IV infusion (240 mg) every 2 weeks.
• Experimental: Part E: NSCLC: IPI-549 and nivolumab
  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.
• Experimental: Part E: Melanoma: IPI-549 and nivolumab
  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.
• Experimental: Part E: SCCHN: IPI-549 and nivolumab
  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.
• Experimental: Part F: TNBC: IPI-549 and nivolumab
  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.
• Experimental: Part G: ACC: IPI-549 and nivolumab
  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.
• Experimental: Part G: Mesothelioma: IPI-549 and nivolumab
  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.
• Experimental: Part H: High-circulating MDSCs: IPI-549 and nivolumab
  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.

Primary Outcome Measure

Part A/B/C: Dose Limiting Toxicities (DLT) [ Time Frame: From date of initial dose until up to 28 days for IPI-549 ]

Locations (11)

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