drugset / Trial / NCT07847957
Roginolisib Plus Obinutuzumab + Venetoclax in R/R CLL
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |