Trial Title:
A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
NCT ID:
NCT06393738
Condition:
Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)
Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, B-Cell
Immunoblastic Lymphadenopathy
Conditions: Keywords:
Relapsed/Refractory B cell Non Hodgkin Lymphoma (NHL)
Relapsed/Refractory Angioimmunoblastic T-cell lymphoma (AITL)
Advanced non-Hodgkin Lymphoma
advanced NHL
relapsed non-Hodgkin Lymphoma
refractory non-Hodgkin Lymphoma
B Cell Advanced Non-Hodgkin Lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
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 purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ARV-393
Description:
Oral dose of ARV-393 at a specified dose schedule will be taken in 28-day cycles
Arm group label:
Dose escalation
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.
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinical Trial Site
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
New Brunswick
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Cleveland
Zip:
44122
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Odense C
Zip:
5000
Country:
Denmark
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Barcelona
Zip:
8908
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Clinical Trial Site
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Start date:
September 5, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Arvinas Inc.
Agency class:
Industry
Source:
Arvinas Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06393738
