A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
Condition(s) studied
Investigational drug(s) / intervention(s)
ARV-393: Oral daily dose of ARV-393 at a specified dose level
Glofitamab: Glofitamab infusion per labelled prescribing information
Study summary
This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma (R/R NHL) to determine if ARV-393 may be a possible treatment option.
ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.
Eligibility
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicities During First 28 Days — 28 days from first study dosing
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) - Percentage of Participants With Adverse Events Characterized by Severity, Seriousness, and Relationship to Study Drug as a Measure of Safety and Tolerability — Parts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393
Adverse events as characterized by type, frequency, severity, seriousness, and relationship to study drug - Number of Participants With Abnormal Vital Signs, Abnormal ECG Readings (QT Interval) and Abnormal Laboratory Parameters — Parts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393
Shifts in vital signs, ECGs, and laboratory parameters from study baseline - Percentage of Participants With Grade 3 or Grade 4 Clinical Lab Abnormalities Using the Common Terminology Criteria for Adverse Events (CTCAE) With Scale From Grade 1 Grade 5. Higher Score Means Worse Outcome — Parts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393
Incidence of Grade 3 and Grade 4 clinical laboratory abnormalities
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Trial Site | New Haven | Connecticut | Recruiting |
| Clinical Trial Site | Miami | Florida | Recruiting |
| Clinical Trial Site | Detroit | Michigan | Recruiting |
| Clinical Trial Site | New Brunswick | New Jersey | Recruiting |
| Clinical Trial Site | New York | New York | Recruiting |
| Clinical Trial Site | New York | New York | Recruiting |
| Clinical Trial Site | Cleveland | Ohio | Recruiting |
| Clinical Trial Site | Nashville | Tennessee | Withdrawn |
| Clinical Trial Site | Houston | Texas | Recruiting |
| Clinical Trial Site | Charlottesville | Virginia | Recruiting |
| Clinical Trial SIte | East Melbourne | Victoria | Recruiting |
| Clinical Trial SIte | Calgary | Alberta | Recruiting |
| Clinical Trial Site | Toronto | Ontario | Recruiting |
| Clinical Trial Site | Montreal | Quebec | Recruiting |
| Clinical Trial Site | Copenhagen | Denmark | Recruiting |
| Clinical Trial Site | Odense C | Denmark | Recruiting |
| Clinical Trial Site | El Palmar | Murcia | Recruiting |
| Clinical Trial Site | Pamplona | Navarre | Recruiting |
| Clinical Trial Site | Barcelona | Spain | Recruiting |
| Clinical Trial Site | Madrid | Spain | Recruiting |
| Clinical Trial Site | Salamanca | Spain | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06393738 on ClinicalTrials.gov ↗ ← All trials in Spain