Trial Title:
A Safety Study of SGN-35T in Adults With Advanced Cancers
NCT ID:
NCT06120504
Condition:
Lymphoma, T-Cell, Cutaneous
Hodgkin Disease
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Brentuximab Vedotin
Conditions: Keywords:
cHL
ALCL
PCL
PTCL
DLBCL
CTCL
Non-Hodgkin Lymphoma
Seattle Genetics
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGN-35T
Description:
Given into the vein (IV; intravenously)
Arm group label:
SGN-35T
Summary:
This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood
cells that fight infections. There are several types of lymphoma. This study will enroll
people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma
including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or
types of primary cutaneous lymphoma.
This clinical trial uses a drug called SGN-35T. The study drug is in testing and has not
been approved for sale. This is the first time SGN-35T will be used in people. The study
drug will be given as an infusion through a vein.
This study will test the safety of SGN-35T in participants with lymphoma. It will also
study the side effects of this drug. A side effect is anything a drug does to the body
besides treating the disease.
This study will have three parts. Parts A and B of the study will find out the best dose
and dosing schedule for SGN-35T. Part C will use the dose found in parts A and B to find
out how safe SGN-35T is and if it works to treat select lymphomas.
Detailed description:
This is a phase 1, open-label, multicenter study designed to characterize the safety,
tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of SGN-35T in
adults with select relapsed/refractory lymphomas. SGN-35T is a CD30-directed
antibody-drug conjugate and will be studied in patients with lymphomas expressing CD30.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Disease indication
- For dose escalation and dose optimization (Part A and Part B):
- Participants with a histologically confirmed lymphoid neoplasm (including
relapsed/refractory [R/R] classical Hodgkin lymphoma [cHL], R/R peripheral
T-cell lymphoma [PTCL], R/R systemic anaplastic large cell lymphoma
[sALCL] , R/R mature B-cell neoplasms, and select R/R primary cutaneous
lymphomas [PCLs]) who in the judgment of the investigator have no
appropriate standard therapy available at the time of enrollment and are a
candidate for SGN-35T treatment.
- Participants must have a detectable CD30 expression level (≥1%) in tumor
tissue (except cHL and ALCL where CD30 is universally expressed).
- For dose expansion (Part C)
- Participants are eligible irrespective of CD30 expression on tumor tissue.
- Participants with cHL: Participants with R/R cHL who have received at
least 3 prior systemic therapies (autologous stem cell transplant [ASCT]
and the associated high dose chemotherapy prior to ASCT are considered to
be 1 prior line) and meet all of the following additional criteria:
- Participants who have not received ASCT must have refused or been
deemed ineligible.
- Participants must have received or been ineligible to receive an
anti-PD-1 agent.
- Participants with PTCL:
- Participants with R/R PTCL (excluding R/R sALCL) who have received at
least 2 prior systemic therapies or received at least 1 prior
systemic therapy and there is no other available treatment that is
considered appropriate by the investigator.
- Participants with R/R sALCL must have ALK status documented and must
meet one of the following criteria:
- Disease recurrence or progression following at least 2 prior
systemic therapies where 1 regimen included brentuximab vedotin,
or
- Disease recurrence or progression following only 1 prior line of
therapy which included brentuximab vedotin, cyclophosphamide,
doxorubicin, and prednisone
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.
- Fluorodeoxyglucose positron emission tomography (FDG PET) avid and bidimensional
measurable disease as documented by radiographic technique (spiral CT preferred) per
Lugano criteria at baseline (Cheson 2014) (not applicable for subjects with PCL).
Exclusion Criteria:
- Previous exposure to CD30 targeted therapy (exception: participants with cHL, PTCL,
or PCL may have received prior brentuximab vedotin but no more than 2 prior
brentuximab vedotin based lines of therapy and at least 3 months should have elapsed
before enrollment).
- History of another malignancy within 3 years before the first dose of study
intervention, or any evidence of residual disease from a previously diagnosed
malignancy. Exceptions are malignancies with a negligible risk of metastasis or
death.
- Active cerebral/meningeal disease related to the underlying malignancy.
- Received previous ASCT infusion <12 weeks prior to first SGN-35T dose.
- Participants with previous allogeneic stem cell transplant (SCT) if they meet any of
the following criteria:
- <100 days from allogeneic SCT. Participants ≥100 days from allogeneic SCT who
are stable without immunosuppressive therapy for at least 12 weeks are
permitted.
- Active acute or chronic graft versus host disease or receiving
immunosuppressive therapy as treatment for or prophylaxis against graft versus
host disease.
- Cytomegalovirus (CMV) PCR ≥500 IU/mL, OR rising DNA levels >5-times baseline within
1 month, OR detectable CMV PCR receiving pre-emptive therapy; prior PCR positivity
that was successfully treated is acceptable provided the baseline PCR result is
negative prior to the first dose of study drug.
- Grade 2 or higher pulmonary disease unrelated to underlying malignancy, or history
of Grade 2 or higher drug-induced interstitial lung disease (ILD) or immune
checkpoint inhibitor (ICI)-related ILD.
- Clinically significant lung disease requiring systemic corticosteroid treatment
within 6 months prior to enrollment or who are suspected to have such diseases via
radiographic imaging and/or functional tests conducted during the screening period.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cesar Gentille Sanchez
Email:
CGentille@UAMS.EDU
Investigator:
Last name:
Cesar Gentille Sanchez
Email:
Principal Investigator
Facility:
Name:
Stanford Cancer Center / Blood and Marrow Transplant Program
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Youn Kim
Email:
younkim@stanford.edu
Investigator:
Last name:
Youn Kim
Email:
Principal Investigator
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Terry-Ann Lynch
Phone:
305-243-9448
Email:
tlynch@med.miami.edu
Investigator:
Last name:
Craig Moskowitz
Email:
Principal Investigator
Facility:
Name:
University of Illinois at Chicago
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Rubinstein
Email:
paulgr@uic.edu
Investigator:
Last name:
Paul Rubinstein
Email:
Principal Investigator
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
HCCC CT.GOV RegDocProDevMon
Email:
HCCC-RegDocProDevMon@healthcare.uiowa.edu
Investigator:
Last name:
Eric Mou
Email:
Principal Investigator
Facility:
Name:
Regional Cancer Care Associates - Central Jersey
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tatyana Feldman
Phone:
973-699-2835
Email:
tatyana.feldman@hmhn.org
Investigator:
Last name:
Tatyana Feldman
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alison Moskowitz
Phone:
646-227-3010
Email:
moskowia@mskcc.org
Investigator:
Last name:
Alison Moskowitz
Email:
Principal Investigator
Facility:
Name:
University of Tennessee
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Completed
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hun Ju Lee, MD
Phone:
713-745-4367
Email:
hunlee@mdanderson.org
Investigator:
Last name:
Hun Ju Lee, MD
Email:
Principal Investigator
Facility:
Name:
Rigshospitalet University Hospital of Copenhagen
Address:
City:
Copenhagen
Zip:
DK-2100
Country:
Denmark
Status:
Recruiting
Investigator:
Last name:
Martin Hutchings
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Daniel Morillo
Email:
Principal Investigator
Facility:
Name:
University College London Hospitals NHS Foundation Trust
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
William Townsend
Email:
Principal Investigator
Start date:
February 29, 2024
Completion date:
April 30, 2030
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120504
