Study Results
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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TERMINATED
PHASE1
133 participants
INTERVENTIONAL
2020-05-29
2023-12-01
Brief Summary
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The study will have four 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. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SEA-TGT Monotherapy (Parts A and B)
SEA-TGT
SEA-TGT
Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
SEA-TGT + sasanlimab Combination Therapy (Part C)
SEA-TGT + sasanlimab
SEA-TGT
Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
sasanlimab
Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle
SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
SEA-TGT + brentuximab vedotin
SEA-TGT
Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
brentuximab vedotin
Given by IV on Day 1 of each 21-day cycle
Interventions
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SEA-TGT
Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
sasanlimab
Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle
brentuximab vedotin
Given by IV on Day 1 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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 (less than or equal to \[≤\] 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 archival tumor tissue from the most recent biopsy (≤12 months from screening). If archival tissue is not available, a fresh baseline tumor biopsy that has not been previously irradiated is required for any participant whose tumors are considered accessible and appropriate in the opinion of the investigator.
* Histologically- or cytologically-confirmed advanced stage cHL
* cHL patients that have failed standard of care for R/R disease including prior treatment with BV.
* FDG PET emission tomography avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
* ECOG performance status of ≤ 2
* Participants are required to have tumor tissue, if available, from the most recent biopsy (≤12 months from screening) prior to start of study treatment. If archival tissue is not available, a fresh screening tumor biopsy is required 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 (greater than \[\>\]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
* 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.
Exclusion Criteria
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment that has not been completed before the first dose of study drug within the timeframe as follows:
* Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks
* Palliative radiotherapy (≤2 weeks of radiotherapy to non-central nervous system \[CNS\] disease): ≤7 days prior to start of SEA-TGT
* Immune-checkpoint inhibitors: 4 weeks
* Monoclonal antibodies, antibody-drug conjugates (ADC), or radioimmunoconjugates: 4 weeks (2 weeks with documented disease progression)
* T-cell or other cell-based therapies: 12 weeks
* Known CNS metastases
* Participants with a history of CNS metastases are allowed if they have undergone treatment for the CNS disease, symptoms have resolved, and steroids have been discontinued.
* Leptomeningeal involvement by malignant disease is excluded regardless of prior treatment.
* History of another malignancy within 2 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
* Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune mediated pneumonitis.
* Previous therapy with an anti-PD-1 or anti-PD-L1 inhibitor.
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment that has not been completed before the first dose of study drug within the timeframe as follows:
* Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks
* Palliative radiotherapy (≤2 weeks of radiotherapy to non-CNS disease): ≤7 days prior to start of SEA-TGT.
* Immune-checkpoint inhibitors: 4 weeks
* Monoclonal antibodies, ADC, or radioimmunoconjugates: 4 weeks (2 weeks with documented disease progression)
* T-cell or other cell-based therapies: 12 weeks
* Known active CNS metastases.
* Participants with a history of CNS metastases are allowed if they have undergone treatment for the CNS disease, symptoms have resolved, and steroids have been discontinued.
* Leptomeningeal involvement by malignant disease is excluded regardless of prior treatment.
* Known hypersensitivity to any excipient contained in the drug formulation of SEA-TGT or sasanlimab
* Participants with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology-based therapy (prior autoimmune colitis, pneumonitis, transaminitis); Participants with vitiligo, controlled type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* History of interstitial lung disease
* 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.
* Prior use of any anti-TIGIT mAb
* History of another malignancy within 2 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment that has not been completed before the first dose of study drug within the timeframe as follows:
* Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks
* Palliative radiotherapy (≤2 weeks of radiotherapy to CNS disease): ≤7 days prior to start of SEA-TGT
* Immune-checkpoint inhibitors: 4 weeks
* Monoclonal antibodies, ADC (except brentuximab vedotin), or radioimmunoconjugates: 4 weeks (2 weeks with documented disease progression)
* T-cell or other cell-based therapies: 12 weeks
* Known active CNS involvement by lymphoma
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andres Forero-Torres, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
California Research Institute
Los Angeles, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Weill Cornell Medicine
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
University of Alberta / Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network, Princess Margaret Hospital
Toronto, Other, Canada
Institut Gustave Roussy
Villejuif, Other, France
Istituto Europeo di Oncologia
Milan, Other, Italy
Policlinico Universitario Agostino Gemelli
Rome, Other, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Other, Spain
L'Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Other, Spain
HM Centro Integral Oncologico Clara Campal
Madrid, Other, Spain
Sarah Cannon Research Institute UK
London, Other, United Kingdom
The Royal Marsden Hospital (Surrey)
Sutton, Other, United Kingdom
Countries
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Other Identifiers
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C5791001
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004748-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SGNTGT-001
Identifier Type: -
Identifier Source: org_study_id
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