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A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma


Description

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.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.

Trial Eligibility

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.

Study Info

Organization

Arvinas Inc.


Primary Outcome

Incidence of Dose limiting toxicities during Cycle 1 (28 days)


Outcome Timeframe 28 days from first study dosing

NCTID NCT06393738

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-09-05

Completion Date 2025-12

Enrollment Target 112

Interventions

DRUG ARV-393

Locations Recruiting

Clinical Trial Site

United States, Michigan, Detroit


Clinical Trial Site

United States, New Jersey, New Brunswick


Clinical Trial Site

United States, New York, New York


Clinical Trial Site

United States, Ohio, Cleveland


Clinical Trial Site

United States, Tennessee, Nashville


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