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roginolisib

DRUG6 trials

Sponsors

Jennifer R. Brown, MD, PhD, iOnctura, The Lymphoma Academic Research Organisation, St Vincent's Hospital, Sydney

Conditions

Advanced Non Squamous NSCLCChronic Lymphocytic LeukemiaLeukemiaMyelofibrosis (MF)Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Ocular MelanomaPeripheral T Cells Lymphoma (PTCL)Refractory Leukemia

Phase 1

Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
RecruitingNCT06644183
Jennifer R. Brown, MD, PhDChronic Lymphocytic Leukemia, Leukemia, Refractory Leukemia +2
Start: 2025-03-19End: 2032-10-01Target: 64Updated: 2026-02-11
A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients
Active, not recruitingNCT06879717
iOncturaAdvanced Non Squamous NSCLC, Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Start: 2025-04-22End: 2028-01-01Target: 45Updated: 2026-01-16
A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
RecruitingNCT06887803
iOncturaMyelofibrosis (MF)
Start: 2025-11-17End: 2028-07-01Target: 26Updated: 2026-01-16
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
RecruitingNCT07018752
The Lymphoma Academic Research OrganisationPeripheral T Cells Lymphoma (PTCL)
Start: 2025-08-20End: 2030-01-01Target: 49Updated: 2026-02-11
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
RecruitingNCT07203391
St Vincent's Hospital, SydneyUveal Melanoma, Metastatic
Start: 2025-12-01End: 2029-12-01Target: 8Updated: 2025-10-02

Phase 2

A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma
Active, not recruitingNCT06717126
iOncturaOcular Melanoma, Uveal Melanoma
Start: 2025-02-27End: 2028-12-01Target: 85Updated: 2026-01-16

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
PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas
Blood2025-11-03
The selective PI3Kδ inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK inhibitor-refractory/resistant patients with myelofibrosis
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
A phase II randomised study to evaluate the antitumour activity of roginolisib, a novel non-ATP competitive and allosteric modulator inhibiting PI3Kδ, in patients with metastatic uveal melanoma (OCULE-01).
Journal of Clinical Oncology2025-05-28