Breast Cancer Clinical Trial

A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer

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.

View Eligibility Criteria

Eligibility Criteria

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:

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

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 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.

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, 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 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.
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, antibody-drug conjugates, 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

397

Study ID:

NCT04254107

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 33 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Jenny King
Contact
205-996-4279
[email protected]
Amitkumar Mehta
Principal Investigator
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85710, United States More Info
Sudhir Manda
Principal Investigator
City of Hope National Medical Center
Duarte California, 91010, United States More Info
Jasmine Zain
Principal Investigator
University of California at San Francisco
San Francisco California, 94134, United States More Info
Bridget Keenan
Contact
415-476-1528
[email protected]
Bridget Keenan
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06520, United States More Info
Francine Foss
Principal Investigator
Johns Hopkins Medical Center
Baltimore Maryland, 21287, United States More Info
Vincent Lam
Principal Investigator
Maryland Oncology Hematology, P.A.
Rockville Maryland, 20850, United States More Info
John Wallmark
Principal Investigator
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Tycel Phillips
Principal Investigator
Minnesota Oncology Hematology P.A.
Minneapolis Minnesota, 55404, United States More Info
Timothy Larson
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Ashley Moyer
Contact
507-284-0923
[email protected]
Stephen Ansell
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
Jessica Solise
Contact
601-984-1963
[email protected]
Shou-Ching Tang
Principal Investigator
Weill Cornell Medicine
New York New York, 10021, United States More Info
Anna Pavlick
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Alison Moskowitz
Principal Investigator
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem North Carolina, 27157, United States More Info
Amanda Gregson
Contact
336-716-2011
[email protected]
Ravi Paluri
Principal Investigator
University of Cincinnati Cancer Institute
Cincinnati Ohio, 45219, United States More Info
Emily Curran
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Lynn Freitas
Contact
503-215-6054
[email protected]
Christina Lopez
Contact
503-215-5696
[email protected]
Rachel Sanborn
Principal Investigator
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Barbara Stadterman
Contact
412-647-2811
[email protected]
Diwakar Davar
Principal Investigator
Vanderbilt University Medical Center
Nashville Tennessee, 37204, United States More Info
Marta Ann Crispens
Principal Investigator
Texas Oncology - Austin Midtown
Austin Texas, 78705, United States More Info
Jason Melear
Principal Investigator
Texas Oncology - Baylor Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Carlos Becerra
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Tanisha Bell
Contact
713-834-6398
[email protected]
Ecaterina Ileana-Dumbrava
Principal Investigator
Texas Oncology - Tyler
Tyler Texas, 75702, United States More Info
Donald Richards
Principal Investigator
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Blacksburg Virginia, 24060, United States More Info
Paul Richards
Principal Investigator
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States More Info
Alexander Spira
Principal Investigator
Carbone Cancer Center / University of Wisconsin
Madison Wisconsin, 53792, United States More Info
Nataliya Uboha
Principal Investigator
University of Alberta / Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Jennifer Spratlin
Principal Investigator
University Health Network, Princess Margaret Hospital
Toronto Other, M5G 2, Canada More Info
Lillian Siu
Principal Investigator
Institut Gustave Roussy
Villejuif Cedex Other, 94805, France More Info
Vincent Ribrag
Principal Investigator
Istituto Europeo di Oncologia
Milano Other, 20141, Italy More Info
Giuseppe Curigliano
Principal Investigator
Hospital Universitario Vall d'Hebron
Barcelona Other, 08035, Spain More Info
Elena Garralda Cabanas
Principal Investigator
HM Centro Integral Oncologico Clara Campal
Madrid Other, 28050, Spain More Info
Emiliano Calvo
Principal Investigator
Sarah Cannon Research Institute UK
London Other, W1G 6, United Kingdom More Info
Hendrik-Tobias Arkenau
Principal Investigator
The Royal Marsden Hospital (Surrey)
Sutton Other, SM2 5, United Kingdom More Info
Anna Minchom
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

397

Study ID:

NCT04254107

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.