Testing ARV-393 for advanced non-Hodgkin lymphoma
Official title: A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma
Run by Arvinas Inc. · NCT06393738 · Data updated 2026-11-12
This study is testing a new oral drug called ARV-393 to see if it can help slow down or stop tumor growth in people with advanced non-Hodgkin lymphoma that hasn't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 329 (estimated) |
| Sponsor | Arvinas Inc. Industry-sponsored |
| Drugs / interventions | rituximab, chimeric antigen receptor, glofitamab |
| Locations | 21 sites (New Haven, Connecticut and 20 other locations) |
| Status | Recruiting |
| Started | September 5, 2024 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT06393738 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with relapsed/refractory mature B-cell non-Hodgkin lymphoma or angioimmunoblastic T-cell lymphoma who have undergone at least two prior systemic therapies.
✕Probably not a fit
Patients who have undergone recent stem cell transplants or significant prior treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and potential anti-tumor activity of ARV-393, an investigational drug, in patients with advanced relapsed/refractory non-Hodgkin lymphoma. The study is an open-label, multicenter, phase 1, dose escalation trial that aims to determine if ARV-393 can effectively slow or stop tumor growth by targeting a specific protein associated with these lymphomas. Participants will receive ARV-393 in the form of an oral tablet, and the study will assess both tolerability and preliminary efficacy.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with advanced non-Hodgkin lymphoma who have limited alternatives.
How similar studies have gone: While this approach is novel, similar studies targeting specific proteins in non-Hodgkin lymphoma have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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%.
Where it's running
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Clinical Trial Site
New Haven, Connecticut, United States Recruiting -
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Miami, Florida, United States Recruiting -
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Detroit, Michigan, United States Recruiting -
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New Brunswick, New Jersey, United States Recruiting -
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New York, New York, United States Recruiting -
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New York, New York, United States Recruiting
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Cleveland, Ohio, United States Recruiting -
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Houston, Texas, United States Recruiting -
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Charlottesville, Virginia, United States Recruiting -
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East Melbourne, Victoria, Australia Recruiting -
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Calgary, Alberta, Canada Recruiting -
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Toronto, Ontario, Canada Recruiting -
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Montreal, Quebec, Canada Recruiting -
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Copenhagen, Denmark Recruiting -
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Odense C, Denmark Recruiting -
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El Palmar, Murcia, Spain Recruiting -
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Pamplona, Navarre, Spain Recruiting -
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Barcelona, Spain Recruiting -
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Madrid, Spain Recruiting -
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Salamanca, Spain Recruiting -
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Nashville, Tennessee, United States Withdrawn
Study contacts
- Study coordinator: Arvinas Operations, Inc.
- Email: clinicaltrialsARV-393@arvinas.com
- Phone: 475-345-0791
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This study tests ARV-6723, by itself or with pembrolizumab, to see if it is safe and could help the immune system fight advanced solid tumors in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.