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Testing ARV-393 for advanced non-Hodgkin lymphoma

A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma

Phase 1 Interventional Arvinas Inc. · NCT06393738

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

PhasePhase 1
Study typeInterventional
Enrollment255 (estimated)
Ages18 Years and up
SexAll
SponsorArvinas Inc. Industry-sponsored
Drugs / interventionsrituximab, glofitamab
Locations17 sites (New Haven, Connecticut and 16 other locations)
Trial IDNCT06393738 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who have undergone recent stem cell transplants or significant prior treatments may not benefit from this study.

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 performed: While this approach is novel, similar studies targeting specific proteins in non-Hodgkin lymphoma have shown promise, indicating potential for success.

Eligibility criteria

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).
* Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
* 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 this trial is running

New Haven, Connecticut and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Mature B Cell Non Hodgkin LymphomaRelapsed/Refractory Angioimmunoblastic T-cell LymphomaRelapsed/Refractory B cell Non Hodgkin LymphomaRelapsed/Refractory Angioimmunoblastic T-cell lymphomaAdvanced non-Hodgkin Lymphomaadvanced NHLrelapsed non-Hodgkin Lymphomarefractory non-Hodgkin Lymphoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.