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

Last updated: February 6, 2026
Sponsor: Arvinas Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Non-hodgkin's Lymphoma

Treatment

ARV-393

Glofitamab

Clinical Study ID

NCT06393738
ARV-393-101
2023-510136-36-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 demonstratedclinical benefit per investigator assessment or, histologically confirmed AITL thathas recurred or progressed following institutional standard of care therapy.

  • For Part C and D: Have R/R DLBCL, not otherwise specified [NOS (DLBCL, NOS)] orlarge B-cell lymphoma (LBCL) arising from follicular lymphoma and have received twoor more lines of systemic therapy.

  • Have at least one bi dimensionally measurable lesion >1.5-centimeter (cm) in largestdimension 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 CNSlymphoma).

  • Adequate bone marrow function

  • Adequate kidney function

  • Adequate Liver Function

Exclusion

Exclusion Criteria:

  • Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia andsystemic symptoms (DRESS).

  • Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.

  • Any other active malignancy within 3 years prior to enrollment, except foradequately treated basal cell or squamous cell skin cancer, melanoma in situ orcarcinoma in situ of the breast or cervix, and prostate cancer with activesurveillance.

  • 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 (AVblock), unstable angina, coronary/peripheral artery bypass graft, symptomaticcongestive heart failure (CHF), New York Heart Association Class III or IV;

  • Cerebrovascular accident, transient ischemic attack, symptomatic pulmonaryembolism, and/or other clinically significant episode of thromboembolicdisease;

  • Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previousgastric 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 relevantabnormalities that may affect participant safety or interpretation of study results.

  • Cardiac ejection fraction <45%.

Study Design

Total Participants: 255
Treatment Group(s): 2
Primary Treatment: ARV-393
Phase: 1
Study Start date:
September 05, 2024
Estimated Completion Date:
March 31, 2028

Study Description

This is an open-label, global, multi-center monotherapy and combination dose escalation and dose optimization study to evaluate safety, tolerability and preliminary efficacy of ARV-393. The study will evaluate the safety and tolerability in ascending doses of ARV-393 as monotherapy (A) and in combination with glofitamab (C), as well as determine the RP2D in the dose optimization parts (B for monotherapy) and in combination with glofitamab (D for combination therapy). The monotherapy portions of the study will include participants with R/R NHL. The combination therapy portions of the study with glofitamab will include participants with R/R DLBCL.

Connect with a study center

  • Clinical Trial Site

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • Clinical Trial Site

    Toronto 6167865, Ontario 6093943 M5G 1Z5
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Clinical Trial Site

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Clinical Trial Site

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • Clinical Trial Site

    Odense C, 5000
    Denmark

    Site Not Available

  • Clinical Trial Site

    Odense C 11746507, 5000
    Denmark

    Active - Recruiting

  • Clinical Trial Site

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Clinical Trial Site

    El Palmar 2518294, Murcia 2513413 30120
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinical Trial Site

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Barcelona, 8908
    Spain

    Site Not Available

  • Clinical Trial Site

    Barcelona 3128760, 8908
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Madrid, 28050
    Spain

    Site Not Available

  • Clinical Trial Site

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Salamanca, 37007
    Spain

    Site Not Available

  • Clinical Trial Site

    Salamanca 3111108, 37007
    Spain

    Active - Recruiting

  • Clinical Trial Site

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Clinical Trial Site

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Clinical Trial Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Clinical Trial Site

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Clinical Trial Site

    New Brunswick, New Jersey 10065
    United States

    Site Not Available

  • Clinical Trial Site

    New Brunswick 5101717, New Jersey 5101760 10065
    United States

    Active - Recruiting

  • Clinical Trial Site

    New York, New York 10021
    United States

    Site Not Available

  • Clinical Trial Site

    Westbury, New York 11590
    United States

    Site Not Available

  • Clinical Trial Site

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Clinical Trial Site

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland 5150529, Ohio 5165418 44122
    United States

    Active - Recruiting

  • Clinical Trial Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Clinical Trial Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Clinical Trial Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Clinical Trial Site

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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