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IOA-244

DRUG5 trials

Sponsors

iOnctura SA, LYSARC, iOnctura

Conditions

Advanced Metastatic Ocular/Uveal MelanomaMyelofibrosisMyelofibrosis (MF) unresponsive to JAK inhibitorsNSCLCNon-Hodgkin Lymphoma, AdultRELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMASSolid Tumor, AdultUveal Melanoma

Phase 1

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers
Active, not recruitingNCT04328844
iOncturaMyelofibrosis, Non-Hodgkin Lymphoma, Adult, NSCLC +2
Start: 2020-02-25End: 2027-03-01Target: 210Updated: 2026-03-30
A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) who are Unresponsive to JAK inhibitors (HEMA-MED)
RecruitingCTIS2024-515252-20-00
iOnctura SAMyelofibrosis (MF) unresponsive to JAK inhibitors
Start: 2025-03-14Target: 27Updated: 2025-11-11
A Phase I/IIa Study of Roginolisib in combination with dostarlimab with or without docetaxel in patients with advanced non-squamous NSCLC who have progressed on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy (PULMO-01).
Active, not recruitingCTIS2024-517741-14-00
iOnctura SAadvanced non-squamous non-small cell lung cancer (NSCLC)
Start: 2025-04-22Target: 51Updated: 2026-01-23
PLATFORM - A PLATFORM TRIAL, EVALUATING NEW DRUGS OR COMBINATION IN RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMAS
RecruitingCTIS2024-514954-63-00
LYSARCRELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMAS
Start: 2025-08-20Target: 80Updated: 2025-12-03

Phase 2

A Phase II, Multi-centre, Open label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib (IOA-244) in Patients with Advanced/Metastatic Ocular/Uveal Melanoma
RecruitingCTIS2024-514333-37-00
iOnctura SAAdvanced Metastatic Ocular/Uveal Melanoma
Start: 2025-02-25Target: 43Updated: 2025-10-23

Related Papers

Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)
Blood2025-11-03
Trial in progress: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)
Blood2025-11-03
Abstract 2055: Molecular profiling of the PI3Kδ inhibitor roginolisib in metastatic uveal melanoma and its correlation with clinical outcomes
Cancer Research2025-04-21
Roginolisib, an oral, highly selective and allosteric modulator of phosphoinositide 3-kinase inhibitor delta (PI3Kδ) in patients with uveal melanoma and advanced cancers.
Journal of Clinical Oncology2024-06-013 citations
Roginolisib a Highly Selective Allosteric Modulator of the Phosphoinositide 3-Kinase Delta (PI3Kδ) in Patients with Refractory/Relapsed Follicular Lymphoma
Blood2023-11-021 citations
First-in-human (FIH) phase I dose escalation study (part A) of the first oral allosteric modulator of phosphoinositide 3-kinase inhibitor delta (PI3Kδ) roginolisib in patients with advanced cancer and dose confirmation in uveal melanoma (part B).
Journal of Clinical Oncology2023-06-012 citations
Highly Selective Allosteric Modulator of the Phosphoinositide 3‐Kinase Delta (PI3Kδ) Roginolisib In Patients With Refractory/Relapsed Follicular Lymphoma
Hematological Oncology2023-06-012 citations
53P Characterization of the non-ATP competitive PI3Kdelta inhibitor IOA-244 in lymphoma models: From single agent to combination screen and clinical investigation
ESMO Open2023-03-01
First-in-human (FIH) phase I study of the highly selective phosphoinositide 3-kinase inhibitor delta (PI3Kδ) inhibitor IOA-244 in patients with advanced cancer: Safety, activity, pharmacokinetic (PK), and pharmacodynamic (PD) results.
Journal of Clinical Oncology2022-06-017 citations