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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The study will be initiated with the starting dose. The dose may be escalated to higher dose cohorts or de-escalated to lower dose cohorts based upon the safety and tolerability and as per a Cohort Review Committee recommendation. Backfill cohorts may be initiated at a previously cleared dose with select NHL subtypes

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

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

Group Type EXPERIMENTAL

ARV-393

Intervention Type DRUG

Oral dose of ARV-393 at a specified dose schedule will be taken in 28-day cycles

Interventions

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ARV-393

Oral dose of ARV-393 at a specified dose schedule will be taken in 28-day cycles

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No