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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04254107
Other study ID # SGNTGT-001
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date May 29, 2020
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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).


Recruitment information / eligibility

Status Terminated
Enrollment 132
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Monotherapy Inclusion Criteria (Parts A and B) - 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: - 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 Combination Inclusion Criteria (Part C) - 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. Combination Inclusion Criteria (Part D) - 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. Monotherapy Exclusion Criteria (Parts A and B) - 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 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. - Previous allogeneic stem cell transplant (SCT). Participants with prior autologous SCT may be eligible if they are >100 days from autologous SCT and fulfill all other inclusion criteria. - 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 Combination Exclusion Criteria (Part C) - 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 Combination Exclusion Criteria (Part D) - 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 - Previous allogeneic SCT. Participants with prior autologous SCT may be eligible if they are >100 days from autologous SCT and fulfill all other inclusion criteria. - 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.

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Canada University of Alberta / Cross Cancer Institute Edmonton Alberta
Canada University Health Network, Princess Margaret Hospital Toronto Other
France Institut Gustave Roussy Villejuif Cedex Other
Italy Istituto Europeo di Oncologia Milano Other
Italy Policlinico Universitario Agostino Gemelli Rome Other
Spain 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
United Kingdom Sarah Cannon Research Institute UK London Other
United Kingdom The Royal Marsden Hospital (Surrey) Sutton Other
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Texas Oncology - Austin Midtown Austin Texas
United States Johns Hopkins Medical Center Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care Blacksburg Virginia
United States University of Cincinnati Cancer Institute Cincinnati Ohio
United States Texas Oncology - Baylor Sammons Cancer Center Dallas Texas
United States City of Hope Duarte California
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States MD Anderson Cancer Center / University of Texas Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States California Research Institute Los Angeles California
United States Carbone Cancer Center / University of Wisconsin Madison Wisconsin
United States Minnesota Oncology Hematology P.A. Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale Cancer Center New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Weill Cornell Medicine New York New York
United States University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Mayo Clinic Rochester Rochester Minnesota
United States Maryland Oncology Hematology, P.A. Rockville Maryland
United States University of California, San Francisco | HDFCCC - Hematopoietic Malignancies San Francisco California
United States Arizona Oncology Associates, PC - HOPE Tucson Arizona
United States Texas Oncology - Northeast Texas Tyler Texas
United States Wake Forest Baptist Medical Center / Wake Forest University Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs) An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Primary Number of participants with laboratory abnormalities by grade To be summarized using descriptive statistics Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Primary Number of participants with a dose-limiting toxicity (DLT) at each dose level To be summarized using descriptive statistics Up to 21 days
Secondary Objective Response Rate (ORR) Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumor response criteria Up to approximately 3 years
Secondary Complete response (CR) rate Proportion of participants with CR per the participant's specific tumor response criteria Up to approximately 3 years
Secondary Duration of objective response Time from first response to the first documentation of disease progression or death due to any cause Up to approximately 3 years
Secondary Duration of CR Time from start of the first documentation of CR to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first Up to approximately 3 years
Secondary Duration of progression-free survival Time from first dose to the first documentation of disease progression or death due to any cause Up to approximately 3 years
Secondary Duration of overall survival Time from start of study treatment to the date of death due to any cause Up to approximately 3 years
Secondary Area under the concentration-time curve (AUC) To be summarized using descriptive statistics. Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Secondary Time to maximum concentration (tmax) To be summarized using descriptive statistics. Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Secondary Maximum concentration (Cmax) To be summarized using descriptive statistics. Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Secondary Trough concentration (Ctrough) To be summarized using descriptive statistics. Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Secondary Number of participants with antidrug antibodies (ADA) To be summarized using descriptive statistics. Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
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