A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

Who is this study for? Adult patients with Advanced or Metastatic Unresectable Non-Small Cell Lung, Head and Neck Cancer, or Lymphoma
What treatments are being studied? SEA-TGT
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas. The study will have three parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Histologically- or cytologically-confirmed advanced or metastatic malignancy, defined as:

• One of the following tumor types:

• Unresectable locally-advanced or metastatic non-small cell lung cancer (NSCLC), gastric/gastroesophageal (GE) junction carcinoma, cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC), bladder cancer, cervical cancer, ovarian cancer, or triple negative breast cancer (TNBC)

• Lymphomas, including:

• Classical Hodgkin lymphoma (cHL)

• Diffuse large B-cell lymphoma (DLBCL)

• Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)

• Lymphoma: Participants should have disease progression on or after treatment with standard therapies expected to provide benefit in the judgement of the investigator.

• cHL: Participants must have received at least 3 prior systemic therapies. Participants should have had disease recurrence or progression following brentuximab vedotin therapy or have been ineligible to receive brentuximab vedotin. Participants who have not received autologous stem cell transplant (SCT) must have refused or been deemed ineligible. Participants should have received or not be eligible to have received an anti-PD-1 agent.

• DLBCL: Participants must have received at least 2 prior systemic chemo-immunotherapy regimens, including an anti-CD20 agent and combination chemotherapy. Unless clinically contraindicated, participants should have had disease that has relapsed after or be refractory to intensive salvage chemotherapy, including autologous SCT.

• PTCL-NOS: Participants must have had at least 1 prior systemic therapy. Participants must have received or have been ineligible to receive the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy. Participants with CD30-positive disease must have received or be ineligible to receive brentuximab vedotin. Participants must have also received intensive salvage therapy (defined as combination chemotherapy ± autologous SCT) unless they refused or were deemed ineligible.

• Measurable disease defined as:

• Solid tumors: Measurable disease according to RECIST V1.1

• Lymphomas: Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of ≥15 mm in the greatest transverse diameter by computed tomography (CT) scan, as assessed by the site radiologist.

• A representative archival tumor tissue sample should be available as follows: Participants must provide archived tumor tissue, if available, from the most recent biopsy (≤12 months from screening). If archived tissue is not available, a fresh baseline tumor biopsy will be requested for any participant enrolled in Part B whose tumors are considered accessible and appropriate in the opinion of the investigator.

• ECOG Performance Status score of 0 or 1

• ECOG Performance Status score of 0 or 1

• NSCLC: histological or cytological confirmed metastatic disease. Participants must have received no prior anti-PD-1/PD-L1 therapy allowed.

• HNSCC: histological or cytological confirmed metastatic disease. Participants must have received no prior exposure to anti-PD-1/PD-L1 therapy.

• Cutaneous Melanoma: histological or cytological confirmed metastatic disease. Participants must not have received anti-PD-1/PD-L1 targeted therapy.

• Measurable disease by CT or magnetic resonance imaging (MRI) as defined by RECIST V1.1

• Participants must provide archived tumor tissue, if available, from the most recent biopsy (≤12 months from screening). If archived tissue is not available, a fresh screening tumor biopsy will be requested for any participant whose tumors are considered accessible and appropriate in the opinion of the investigator.

• Prior use of any anti-TIGIT mAb.

• Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids and adrenal replacement steroid doses >10 mg daily prednisone or equivalents are permitted in the absence of active immune disease.

• Known hypersensitivity to any excipient contained in the drug formulation of SEA-TGT

Locations
United States
Alabama
University of Alabama at Birmingham
Recruiting
Birmingham
Arizona
Arizona Oncology Associates, PC - HOPE
Recruiting
Tucson
California
City of Hope National Medical Center
Recruiting
Duarte
University of California at San Francisco
Recruiting
San Francisco
Connecticut
Yale Cancer Center
Recruiting
New Haven
Maryland
Johns Hopkins Medical Center
Recruiting
Baltimore
Maryland Oncology Hematology, P.A.
Recruiting
Rockville
Michigan
University of Michigan Comprehensive Cancer Center
Recruiting
Ann Arbor
Minnesota
Minnesota Oncology Hematology P.A.
Recruiting
Minneapolis
Mayo Clinic Rochester
Recruiting
Rochester
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Wake Forest Baptist Medical Center / Wake Forest University
Recruiting
Winston-salem
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Weill Cornell Medicine
Recruiting
New York
Ohio
University of Cincinnati Cancer Institute
Recruiting
Cincinnati
Oregon
Providence Portland Medical Center
Completed
Portland
Pennsylvania
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Recruiting
Pittsburgh
Tennessee
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Texas Oncology - Austin Midtown
Recruiting
Austin
Texas Oncology - Baylor Sammons Cancer Center
Recruiting
Dallas
MD Anderson Cancer Center / University of Texas
Recruiting
Houston
Texas Oncology - Tyler
Recruiting
Tyler
Virginia
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Recruiting
Blacksburg
Virginia Cancer Specialists, PC
Recruiting
Fairfax
Wisconsin
Carbone Cancer Center / University of Wisconsin
Recruiting
Madison
Other Locations
Canada
University of Alberta / Cross Cancer Institute
Recruiting
Edmonton
University Health Network, Princess Margaret Hospital
Recruiting
Toronto
France
Institut Gustave Roussy
Recruiting
Villejuif Cedex
Italy
Istituto Europeo di Oncologia
Recruiting
Milano
Spain
Hospital Universitario Vall d'Hebron
Recruiting
Barcelona
HM Centro Integral Oncologico Clara Campal
Recruiting
Madrid
United Kingdom
Sarah Cannon Research Institute UK
Recruiting
London
The Royal Marsden Hospital (Surrey)
Recruiting
Sutton
Contact Information
Primary
Seagen Trial Information Support
clinicaltrials@seagen.com
866-333-7436
Time Frame
Start Date: May 29, 2020
Estimated Completion Date: March 31, 2023
Participants
Target number of participants: 397
Treatments
Experimental: Monotherapy (Parts A and B)
SEA-TGT
Experimental: Combination Therapy (Part C)
SEA-TGT + sasanlimab
Sponsors
Leads: Seagen Inc.

This content was sourced from clinicaltrials.gov

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