Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
roginolisib · 1 trial · 1 indication
mPFS
MTD
RP2D
| Arm | Type | Description |
|---|---|---|
| Origina-ly-T | EXPERIMENTAL | Open-label phase 2 sub-study to evaluate the efficacy and safety of roginolisib in relapsed/refractory peripheral T-cells lymphoma. Study treatment will be administered until unacceptable toxicity, disease progression, subject/physician decision to withdraw, whichever happens first. 31 evaluable patients needed. |
| GolcAza | EXPERIMENTAL | Open-label phase 1 sub-study to identify the maximum tolerated dose of golcadomide in association with oral 5-azacitidine and evaluate the efficacy and safety of the determined combination of oral 5-azacitidine and golcadomide in relapsed/refractory follicular helper T-cell lymphoma subjects. Subjects will receive golcadomide and oral 5-azacitidine until end of study or until disease progression, unacceptable toxicity, subject/physician decision to withdraw, whichever occurs first. Minimum 18 evaluable patient required. |
| Name | Type | Description |
|---|---|---|
| roginolisib | DRUG | Roginolisib daily intake |
| golcadomide | DRUG | Golcadomide daily intake |
| azacitidine | DRUG | oral 5-azacitidine daily intake |
1. Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted; 2. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF); 3. Subject is willing and able to adhere to the study visit sched...
Roginolisib is an investigational small molecule being studied for the treatment of relapsed or refractory Peripheral T Cells Lymphoma (PTCL). It is currently in Phase 1 clinical development, evaluated as part of a platform trial for patients with this condition.
Roginolisib targets PI3K, a class of enzymes involved in cell growth and survival. As a PI3K inhibitor, it is designed to interfere with signaling pathways that can drive cancer cell proliferation in Peripheral T Cells Lymphoma (PTCL).
Roginolisib is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with Peripheral T Cells Lymphoma (PTCL).
Roginolisib is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in a recruiting Phase 1 trial for relapsed or refractory Peripheral T Cells Lymphoma (PTCL).
Roginolisib is being evaluated in clinical trial NCT07018752, titled 'A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas.' This Phase 1, randomized, controlled study is recruiting 49 participants in France, with a minimum age of 18 years.
Roginolisib is a PI3K inhibitor, but it is a distinct investigational drug developed by AbbVie. It is not known to be the same as any other marketed or investigational PI3K inhibitor, and it is being studied specifically for Peripheral T Cells Lymphoma (PTCL).