Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Copanlisib · 1 trial · 3 indications
The highest dose of the drug combination that does not cause unacceptable side effects as assessed by protocol-specified DLT criteria.
Defined as the partial response (PR) and complete response (CR) rate, according to the Lugano criteria.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Copanlisib + Venetoclax | EXPERIMENTAL | Phase 1 * Dose escalation will occur using a 3+3 design * Copanlisib will be administered IV on days 1, 8 and 15 in 28 day cycle * Venetoclax will be administered orally daily for each 28-day cycle. During cycle 1, a venetoclax dose ramp-up is performed in the outpatient setting |
| Recommended phase II dose (RP2D) Copanlisib + Venetoclax | EXPERIMENTAL | Patients will be treated with copanlisib in combination with venetoclax, administered at the Recommended phase II dose (RP2D). |
| Name | Type | Description |
|---|---|---|
| Copanlisib | DRUG | Intravenous infusion |
| Venetoclax | DRUG | Tablet taken orally |
Inclusion Criteria: * A confirmed diagnosis of DLBCL according to the 2016 WHO classification. Patients with high-grade B-cell lymphoma with translocations of MYC and BCL-2 and/or BCL-6 are eligible * Relapsed after autologous stem cell transplantation or chimeric antigen receptor (CAR) T-cell ther...
Copanlisib is an investigational small molecule being studied for the treatment of Diffuse Large B Cell Lymphoma (DLBCL), specifically in patients with relapsed or refractory disease. It is currently in Phase 1 clinical development and has not been approved by the FDA.
Copanlisib targets phosphoinositide 3-kinase (PI3K), as indicated by its '-lisib' suffix. It is being evaluated in combination with venetoclax in a Phase 1 trial for relapsed or refractory Diffuse Large B Cell Lymphoma.
Copanlisib is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting a Phase 1 clinical trial of the drug in patients with relapsed or refractory Diffuse Large B Cell Lymphoma.
Copanlisib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants.
Copanlisib is being studied in the clinical trial NCT04572763, titled 'Copanlisib Plus Venetoclax in R/R DLBCL'. This Phase 1 trial is enrolling 48 participants with relapsed or refractory Diffuse Large B Cell Lymphoma in the United States.
No, Copanlisib is not the same as venetoclax. Copanlisib is a PI3K inhibitor, while venetoclax is a BCL-2 inhibitor. They are being studied in combination in a Phase 1 trial for relapsed or refractory Diffuse Large B Cell Lymphoma.