Ireland
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Recruiting Phase 1

A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.

NCT06393738 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2024-09-05
Last updated
2026-09-04

Condition(s) studied

Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)

Investigational drug(s) / intervention(s)

ARV-393Glofitamab →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 following institutional standard of care therapy. * For Part C and D: Have R/R DLBCL, not otherwise specified \[NOS (DLBCL, NOS)\] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy. * Have at least one bi dimensionally measurable lesion \>1.5-centimeter (cm) in largest dimension for nodal or \>1.0 cm for extranodal lesion. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma). * Adequate bone marrow function * Adequate kidney function * Adequate Liver Function Exclusion Criteria: * Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS), except for peripheral eosinophilia due to disease under study. Participants with current or prior eosinophilia requiring systemic steroid treatment are excluded regardless of etiology. * Prior allogeneic stem cell transplant (SCT) or solid organ transplantation. * Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 60 days prior to Cycle 1 Day 1 (C1D1) or any prior treatment with a BCL6-targeted therapy * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance. * Any of the following in the previous 6 months: * Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes; * Clinically important atrial or ventricular arrhythmias; * Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV; * Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episode of thromboembolic disease; * Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery. * Uncontrolled hypertension despite optimal medical treatment * History of myocarditis. * In ability to comply with listed prohibited treatments. * Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. * Cardiac ejection fraction \<45%.

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)

FacilityCityRegionStatus
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
Official registry record

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