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

NCT04254107 | Terminated Phase 1 FDA Drug

• 3 other identifiers: SGNTGT-001C57910012019-004748-31
• Study Type: interventional
• Target: 133
• Locations: 6 countries
• Sites: 36

Brief 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).

Conditions

Non-small Cell Lung Cancer; Gastric Carcinoma; Gastroesophageal Junction Carcinoma; Classical Hodgkin Lymphoma; Diffuse Large B-cell Lymphoma; Peripheral T-cell Lymphoma; Cutaneous Melanoma; Head and Neck Squamous Cell Carcinoma; Bladder Cancer; Ovarian Cancer; Triple Negative Breast Cancer; Cervical Cancer

Keywords

NSCLC; cHL; HNSCC; TNBC; DLBCL; PTCL-NOS; Seattle Genetics

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Number of participants with a dose-limiting toxicity (DLT) at each dose level

  To be summarized using descriptive statistics

  Up to 21 days

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  Up to approximately 3 years

• Complete response (CR) rate

  Up to approximately 3 years

• Duration of objective response

  Up to approximately 3 years

• Duration of CR

  Up to approximately 3 years

• Duration of progression-free survival

  Up to approximately 3 years

Study Arms (3)

SEA-TGT Monotherapy (Parts A and B)

EXPERIMENTAL

SEA-TGT

Drug: SEA-TGT

SEA-TGT + sasanlimab Combination Therapy (Part C)

EXPERIMENTAL

SEA-TGT + sasanlimab

Drug: SEA-TGT; Drug: sasanlimab

SEA-TGT + brentuximab vedotin Combination Therapy (Part D)

EXPERIMENTAL

SEA-TGT + brentuximab vedotin

Drug: SEA-TGT; Drug: brentuximab vedotin

Interventions

SEA-TGT DRUG

Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle

Also known as: SGN-TGT

SEA-TGT + brentuximab vedotin Combination Therapy (Part D); SEA-TGT + sasanlimab Combination Therapy (Part C); SEA-TGT Monotherapy (Parts A and B)

sasanlimab DRUG

Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle

SEA-TGT + sasanlimab Combination Therapy (Part C)

brentuximab vedotin DRUG

Given by IV on Day 1 of each 21-day cycle

Also known as: Adcetris

SEA-TGT + brentuximab vedotin Combination Therapy (Part D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (36)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85710, United States

Location

City of Hope

Duarte, California, 91010-3000, United States

Location

California Research Institute

Los Angeles, California, 90027, United States

Location

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, 94134, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Maryland Oncology Hematology, P.A.

Rockville, Maryland, 20850, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Oncology Hematology P.A.

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Wake Forest Baptist Medical Center / Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

Texas Oncology - Austin Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030, United States

Location

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

Location

Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

Blacksburg, Virginia, 24060, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Carbone Cancer Center / University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

University of Alberta / Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

University Health Network, Princess Margaret Hospital

Toronto, Other, M5G 2C1, Canada

Location

Institut Gustave Roussy

Villejuif, Other, 94805, France

Location

Istituto Europeo di Oncologia

Milan, Other, 20132, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Other, 00168, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, Other, 08035, Spain

Location

L'Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Other, 08908, Spain

Location

HM Centro Integral Oncologico Clara Campal

Madrid, Other, 28050, Spain

Location

Sarah Cannon Research Institute UK

London, Other, W1G 6AD, United Kingdom

Location

The Royal Marsden Hospital (Surrey)

Sutton, Other, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell, Peripheral; Melanoma; Squamous Cell Carcinoma of Head and Neck; Urinary Bladder Neoplasms; Ovarian Neoplasms; Triple Negative Breast Neoplasms; Uterine Cervical Neoplasms

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Breast Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Andres Forero-Torres, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: May 29, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

IT (2); GB (2); FR (1); ES (3); CA (2); US (26)