Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06393738 | A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma. | PHASE1 | RECRUITING | 255 | — | — | Sep 5, 2024 | Mar 1, 2028 | Feb 10, 2026 | 17 | United States, Canada +2 |
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...