drugset / Trial / NCT07847957

Roginolisib Plus Obinutuzumab + Venetoclax in R/R CLL

NCT07847957 ↗

Phase 1/2 Not yet recruiting 40 enrolled Dana-Farber Cancer Institute iOnctura · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1b and 2, open-label, single-arm study evaluating the safety, tolerability, and efficacy of roginolisib (IOA-244) in combination with obinutuzumab followed by venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have progressed after prior Bruton Tyrosine Kinase (BTK) inhibitor therapy. The study aims to determine the maximum tolerated dose of roginolisib in combination with obinutuzumab, and to assess the rate of undetectable minimal residual disease (uMRD) after sequential therapy with roginolisib, obinutuzumab, and venetoclax.

Timeline

Start
2027-01-13
Primary completion
2027-04-01
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Subject Venetoclax Small molecule 400 mg Oral
Subject roginolisib Small molecule 40 mg Oral
Subject roginolisib Small molecule 80 mg Oral