A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkin s Lymphoma
Primary:
To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule
secondary:
To characterize the pharmacokinetic profile of ARV-393 in plasma
To assess the preliminary anti-tumor activity of ARV-393
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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