Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARV-393 · 1 trial · 2 indications
Percentage of participants in dose escalation arm at a given dose cohort with AEs meeting protocol defined dose limiting toxicities during cycle 1 (28 days)
Adverse events as characterized by type, frequency, severity, seriousness, and relationship to study drug
Shifts in vital signs, ECGs, and laboratory parameters from study baseline
Incidence of Grade 3 and Grade 4 clinical laboratory abnormalities
| Arm | Type | Description |
|---|---|---|
| Part A Monotherapy Dose escalation | EXPERIMENTAL | Participants with R/R NHL will receive ARV-393 dose escalation beginning at dose level 1 |
| Part B Monotherapy: Dose expansion/optimization | EXPERIMENTAL | Dose expansion and optimization of ARV-393 will be conducted in Part B to determine the recommended phase 2 dose (RP2D) for participants with R/R NHL |
| Part C Combination therapy: Dose escalation | EXPERIMENTAL | Participants with R/R diffuse large B-cell lymphoma (DLBCL) will receive ARV-393 in combination with glofitamab, beginning at an ARV-393 dose informed by the Part A. Glofitamab will be given per labelled prescribing information. Part C will be conducted in non-USA centers. |
| Part D Combination therapy: Dose expansion/optimization | EXPERIMENTAL | Part D will be an optimization of ARV-393 in combination with glofitamab to determine a potential RP2D for ARV-393 in the combination regimen. Part D will be conducted in non-USA centers in participants with R/R DLBCL. |
| Name | Type | Description |
|---|---|---|
| ARV-393 | DRUG | Oral daily dose of ARV-393 at a specified dose level |
| Glofitamab | DRUG | Glofitamab infusion per labelled prescribing information |
Inclusion Criteria: * For Part A and B: Have relapsed/refractory NHL and \>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed follo...
ARV-393 is an investigational small molecule being developed for the treatment of relapsed/refractory (R/R) mature B cell non Hodgkin lymphoma (NHL). It is currently in Phase 1 clinical development and has not been approved by the FDA.
ARV-393 targets BCL6, a protein involved in B cell lymphoma. By targeting BCL6, the drug aims to address the underlying biology of relapsed/refractory mature B cell non Hodgkin lymphoma.
ARV-393 is being developed by Arvinas, Inc., a biopharmaceutical company. Arvinas is publicly traded under the ticker symbol ARVN.
ARV-393 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is actively recruiting participants.
ARV-393 is being studied in a Phase 1 clinical trial with the identifier NCT06393738. The trial is recruiting participants with relapsed/refractory non Hodgkin lymphoma and is being conducted in the United States, Australia, Canada, Denmark, and Spain.
ARV-393 is a specific investigational small molecule that targets BCL6. It is being developed by Arvinas, Inc. for relapsed/refractory mature B cell non Hodgkin lymphoma and is currently in Phase 1 trials.