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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT06393738

Recruitment Status:

Recruiting

Sponsor:

Arvinas Inc.

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There are 7 Locations for this study

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Clinical Trial Site
Detroit Michigan, 48201, United States
Clinical Trial Site
New Brunswick New Jersey, 10065, United States
Clinical Trial Site
New York New York, 10016, United States
Clinical Trial Site
Westbury New York, 11590, United States
Clinical Trial Site
Cleveland Ohio, 44122, United States
Clinical Trial Site
Nashville Tennessee, 77030, United States
Clinical Trial Site
Houston Texas, 77030, United States
Clinical Trial Site
Pamplona , 31008, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT06393738

Recruitment Status:

Recruiting

Sponsor:


Arvinas Inc.

How clear is this clinincal trial information?

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