Non Hodgkin Lymphoma Clinical Trial
A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
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.
Full 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.
Eligibility Criteria
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.
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There are 7 Locations for this study
Detroit Michigan, 48201, United States
New Brunswick New Jersey, 10065, United States
New York New York, 10016, United States
Westbury New York, 11590, United States
Cleveland Ohio, 44122, United States
Nashville Tennessee, 77030, United States
Houston Texas, 77030, United States
Pamplona , 31008, Spain
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