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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 (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.
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 demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy.
For Part C and D: Have R/R DLBCL, not otherwise specified [NOS (DLBCL, NOS)] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.
Have at least one bi dimensionally measurable lesion >1.5-centimeter (cm) in largest dimension 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 CNS lymphoma).
Adequate bone marrow function
Adequate kidney function
Adequate Liver Function
Exclusion Criteria
Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS).
Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance.
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 (AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV;
Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episode of thromboembolic disease;
Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric 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 relevant abnormalities that may affect participant safety or interpretation of study results.
Cardiac ejection fraction <45%.
Study sponsor and potential other locations can be found 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, 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.