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 also being studied in relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL). The drug is currently in Phase 1 clinical development.
ARV-393 targets BCL6, a protein involved in the regulation of gene expression that is often dysregulated in certain lymphomas. By targeting BCL6, ARV-393 aims to interfere with the survival and proliferation of cancer cells in relapsed/refractory non-Hodgkin lymphoma.
ARV-393 is being developed by Arvinas, Inc., a biopharmaceutical company. Arvinas is publicly traded under the ticker symbol ARVN on the Nasdaq stock exchange.
ARV-393 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate the safety and efficacy of ARV-393 in patients with relapsed/refractory non-Hodgkin lymphoma.
ARV-393 is being studied in a Phase 1 clinical trial with the identifier NCT06393738. This trial is currently recruiting participants and has an estimated enrollment of 329 patients. The study is being conducted in the United States, Canada, Denmark, and Spain, and includes patients with relapsed/refractory mature B cell non-Hodgkin lymphoma and angioimmunoblastic T-cell lymphoma.
ARV-393 is a unique investigational compound developed by Arvinas, Inc. No alternative names have been reported for this drug. It is distinct from other drugs in the same class and is being evaluated specifically for its potential in treating relapsed/refractory non-Hodgkin lymphoma.