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

Launched by ARVINAS INC. · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is examining a new drug called ARV-393 to see if it is safe and effective for treating advanced forms of non-Hodgkin lymphoma (NHL) that have not responded to previous treatments. ARV-393 is taken as a tablet and is designed to work by breaking down a specific protein that may help tumors grow, potentially slowing or stopping the cancer's progression. This is the first time people will be using this drug in a study.

To participate in this trial, individuals must be at least 18 years old and have certain types of non-Hodgkin lymphoma that have relapsed or did not respond to at least two prior treatments. Participants will need to have measurable cancer lesions and good organ function. They should not have had certain recent cancer treatments or significant health issues that could increase risks. If someone joins the study, they will be closely monitored to understand how well the drug works and what side effects it may cause.

Gender

ALL

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.