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

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

Recruiting
18 years and older
All
Phase 1

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Overview

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.

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.

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 details
    Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)
    Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)

NCT06393738

Arvinas Inc.

18 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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