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

Last updated: March 28, 2025
Sponsor: Arvinas Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Non-hodgkin's Lymphoma

Treatment

ARV-393

Clinical Study ID

NCT06393738
ARV-393-101
  • 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 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:

  • Eligible participants aged ≥18 years.

  • Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 priorsystemic therapies, or histologically confirmed AITL that has recurred or progressedfollowing institutional standard-of-care therapy.

  • Participants must also have ≥1 measurable lesion at study entry

  • Eastern Cooperative Oncology Group performance status of 0 or 1,

  • Freshly biopsied or archival tumor tissue available,

  • Participants with adequate organ function,

  • Participants must accept and follow pregnancy prevention guidance.

Exclusion

Exclusion Criteria:

  • No prior allogeneic stem cell transplant or solid organ transplantation, Autologousstem cell transplant, must not have occurred ≤100 days, previous CAR T-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4weeks, prior to ARV-393 treatment initiation.

  • Participants must not have significant acute or chronic medical illness, includinghypereosinophilic syndrome, active interstitial lung disease or pneumonitis, activeor uncontrolled infection, or the presence of laboratory abnormalities, that placesparticipants at unacceptable risk if participating in this study.

  • Participants with an inability to comply with listed prohibited treatments.

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: ARV-393
Phase: 1
Study Start date:
September 05, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This is an open-label, multicenter, phase 1, dose escalation study to evaluate the safety, tolerability and preliminary anti-tumor activity of ARV-393 as a single agent in adult patients with relapsed/refractory non-Hodgkin lymphoma.

Connect with a study center

  • Clinical Trial Site

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Clinical Trial Site

    Odense C, 5000
    Denmark

    Active - Recruiting

  • Clinical Trial Site

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Barcelona, 8908
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Madrid, 28050
    Spain

    Active - Recruiting

  • Clinical Trial Site

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Clinical Trial Site

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Clinical Trial Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Clinical Trial Site

    New Brunswick, New Jersey 10065
    United States

    Active - Recruiting

  • Clinical Trial Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Clinical Trial Site

    Westbury, New York 11590
    United States

    Site Not Available

  • Clinical Trial Site

    Cleveland, Ohio 44122
    United States

    Active - Recruiting

  • Clinical Trial Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Clinical Trial Site

    Houston, Texas 77030
    United States

    Active - Recruiting

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