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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Clinical Trial Site
RECRUITING
New Haven
Michigan
Clinical Trial Site
RECRUITING
Detroit
New Jersey
Clinical Trial Site
RECRUITING
New Brunswick
New York
Clinical Trial Site
RECRUITING
New York
Clinical Trial Site
RECRUITING
New York
Ohio
Clinical Trial Site
RECRUITING
Cleveland
Tennessee
Clinical Trial Site
RECRUITING
Nashville
Texas
Clinical Trial Site
RECRUITING
Houston
Other Locations
Canada
Clinical Trial Site
RECRUITING
Montreal
Clinical Trial Site
RECRUITING
Toronto
Denmark
Clinical Trial Site
RECRUITING
Copenhagen
Clinical Trial Site
RECRUITING
Odense C
Spain
Clinical Trial Site
RECRUITING
Barcelona
Clinical Trial Site
RECRUITING
El Palmar
Clinical Trial Site
RECRUITING
Madrid
Clinical Trial Site
RECRUITING
Pamplona
Clinical Trial Site
RECRUITING
Salamanca
Contact Information
Primary
Arvinas Corporation, Inc.
clinicaltrialsARV-393@arvinas.com
475-345-0791
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2025-12
Participants
Target number of participants: 112
Treatments
Experimental: Dose escalation
Dose escalation will begin at Dose Level 1. Dose escalation or de-escalation decision will be recommended by the cohort review committee.
Sponsors
Leads: Arvinas Inc.

This content was sourced from clinicaltrials.gov

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