RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-05
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06393738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eligible participants aged ≥18 years.
  2. * Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy.
  3. * Participants must also have ≥1 measurable lesion at study entry
  4. * Eastern Cooperative Oncology Group performance status of 0 or 1,
  5. * Freshly biopsied or archival tumor tissue available,
  6. * Participants with adequate organ function,
  7. * Participants must accept and follow pregnancy prevention guidance.
  1. * No prior allogeneic stem cell transplant or solid organ transplantation, Autologous stem 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 4 weeks, prior to ARV-393 treatment initiation.
  2. * Participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
  3. * Participants with an inability to comply with listed prohibited treatments.

Contacts and Locations

Study Contact

Arvinas Corporation, Inc.
CONTACT
475-345-0791
clinicaltrialsARV-393@arvinas.com

Study Locations (Sites)

Clinical Trial Site
Detroit, Michigan, 48201
United States
Clinical Trial Site
New Brunswick, New Jersey, 10065
United States
Clinical Trial Site
New York, New York, 10016
United States
Clinical Trial Site
Cleveland, Ohio, 44122
United States
Clinical Trial Site
Nashville, Tennessee, 37203
United States
Clinical Trial Site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Arvinas Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-09-05
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Relapsed/Refractory B cell Non Hodgkin Lymphoma (NHL)
  • Relapsed/Refractory Angioimmunoblastic T-cell lymphoma (AITL)
  • Advanced non-Hodgkin Lymphoma
  • advanced NHL
  • relapsed non-Hodgkin Lymphoma
  • refractory non-Hodgkin Lymphoma
  • B Cell Advanced Non-Hodgkin Lymphoma

Additional Relevant MeSH Terms

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