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A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
Trial Status: active
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.
Inclusion Criteria
Eligible participants aged ≥18 years.
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.
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 Criteria
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.
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.
Participants with an inability to comply with listed prohibited treatments.
Additional locations may be listed on ClinicalTrials.gov for NCT06393738.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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.
