NCT04328844

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers

First-in-Human Dose Study of IOA-244 in Patients With Advanced or Metastatic Cancers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: iOnctura · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis)

Conditions

• Solid Tumor, Adult
• Non-Hodgkin Lymphoma, Adult
• NSCLC
• Myelofibrosis
• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	IOA-244	IOA-244 will be administered orally once daily (QD)
DRUG	Avelumab Injection	Avelumab will be administered IV every 2 weeks
DRUG	Pemetrexed	Pemetrexed will be administered IV every 3 weeks
DRUG	Cisplatin	Cisplatin will be administered IV every 3 weeks
DRUG	Ruxolitinib	Ruxolitinib will be administered orally twice a day (BD)

Timeline

• Start date: 2020-02-25
• Primary completion: 2023-12-13
• Completion: 2027-03-01
• First posted: 2020-03-31
• Last updated: 2026-03-30

Locations

3 sites across 2 countries: Italy, United Kingdom