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

Arvinas

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: ARV-393

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393738

ARV-393-101

Details and patient eligibility

About

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.

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Dose escalation

Experimental group

Description:

Dose escalation will begin at Dose Level 1. Dose escalation or de-escalation decision will be recommended by the cohort review committee.

Treatment:

Drug: ARV-393