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

Primary Purpose

Non-small Cell Lung Cancer, Gastric Carcinoma, Gastroesophageal Junction Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SEA-TGT
sasanlimab
brentuximab vedotin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, cHL, HNSCC, TNBC, DLBCL, PTCL-NOS, Seattle Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Arizona Oncology Associates, PC - HOPERecruiting
  • City of HopeRecruiting
  • California Research InstituteRecruiting
  • University of California at San FranciscoRecruiting
  • Yale Cancer Center
  • Johns Hopkins Medical Center
  • Maryland Oncology Hematology, P.A.Recruiting
  • University of Michigan Comprehensive Cancer Center
  • Minnesota Oncology Hematology P.A.Recruiting
  • Mayo Clinic RochesterRecruiting
  • University of Mississippi Medical Center
  • Weill Cornell Medicine
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Wake Forest Baptist Medical Center / Wake Forest UniversityRecruiting
  • University of Cincinnati Cancer Institute
  • Providence Portland Medical Center
  • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
  • Vanderbilt University Medical Center
  • Texas Oncology - Austin MidtownRecruiting
  • Texas Oncology - Baylor Sammons Cancer CenterRecruiting
  • MD Anderson Cancer Center / University of TexasRecruiting
  • Texas Oncology - Northeast TexasRecruiting
  • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer CareRecruiting
  • Virginia Cancer Specialists, PCRecruiting
  • Carbone Cancer Center / University of WisconsinRecruiting
  • University of Alberta / Cross Cancer Institute
  • University Health Network, Princess Margaret Hospital
  • Institut Gustave RoussyRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • L'Institut Catala d'OncologiaRecruiting
  • HM Centro Integral Oncologico Clara CampalRecruiting
  • Sarah Cannon Research Institute UKRecruiting
  • The Royal Marsden Hospital (Surrey)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SEA-TGT Monotherapy (Parts A and B)

SEA-TGT + sasanlimab Combination Therapy (Part C)

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

Arm Description

SEA-TGT

SEA-TGT + sasanlimab

SEA-TGT + brentuximab vedotin

Outcomes

Primary Outcome Measures

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.
Number of participants with laboratory abnormalities by grade
To be summarized using descriptive statistics
Number of participants with a dose-limiting toxicity (DLT) at each dose level
To be summarized using descriptive statistics

Secondary Outcome Measures

Objective Response Rate (ORR)
Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumor response criteria
Complete response (CR) rate
Proportion of participants with CR per the participant's specific tumor response criteria
Duration of objective response
Time from first response to the first documentation of disease progression or death due to any cause
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
Duration of progression-free survival
Time from first dose to the first documentation of disease progression or death due to any cause
Duration of overall survival
Time from start of study treatment to the date of death due to any cause
Area under the concentration-time curve (AUC)
To be summarized using descriptive statistics.
Time to maximum concentration (tmax)
To be summarized using descriptive statistics.
Maximum concentration (Cmax)
To be summarized using descriptive statistics.
Trough concentration (Ctrough)
To be summarized using descriptive statistics.
Number of participants with antidrug antibodies (ADA)
To be summarized using descriptive statistics.

Full Information

First Posted
January 31, 2020
Last Updated
October 23, 2023
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04254107
Brief Title
A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer
Official Title
A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
417 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEA-TGT Monotherapy (Parts A and B)
Arm Type
Experimental
Arm Description
SEA-TGT
Arm Title
SEA-TGT + sasanlimab Combination Therapy (Part C)
Arm Type
Experimental
Arm Description
SEA-TGT + sasanlimab
Arm Title
SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
Arm Type
Experimental
Arm Description
SEA-TGT + brentuximab vedotin
Intervention Type
Drug
Intervention Name(s)
SEA-TGT
Other Intervention Name(s)
SGN-TGT
Intervention Description
Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
sasanlimab
Intervention Description
Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris
Intervention Description
Given by IV on Day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
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.
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Title
Number of participants with laboratory abnormalities by grade
Description
To be summarized using descriptive statistics
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Title
Number of participants with a dose-limiting toxicity (DLT) at each dose level
Description
To be summarized using descriptive statistics
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumor response criteria
Time Frame
Up to approximately 3 years
Title
Complete response (CR) rate
Description
Proportion of participants with CR per the participant's specific tumor response criteria
Time Frame
Up to approximately 3 years
Title
Duration of objective response
Description
Time from first response to the first documentation of disease progression or death due to any cause
Time Frame
Up to approximately 3 years
Title
Duration of CR
Description
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
Time Frame
Up to approximately 3 years
Title
Duration of progression-free survival
Description
Time from first dose to the first documentation of disease progression or death due to any cause
Time Frame
Up to approximately 3 years
Title
Duration of overall survival
Description
Time from start of study treatment to the date of death due to any cause
Time Frame
Up to approximately 3 years
Title
Area under the concentration-time curve (AUC)
Description
To be summarized using descriptive statistics.
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Title
Time to maximum concentration (tmax)
Description
To be summarized using descriptive statistics.
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Title
Maximum concentration (Cmax)
Description
To be summarized using descriptive statistics.
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Title
Trough concentration (Ctrough)
Description
To be summarized using descriptive statistics.
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
Title
Number of participants with antidrug antibodies (ADA)
Description
To be summarized using descriptive statistics.
Time Frame
Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seagen Trial Information Support
Phone
866-333-7436
Email
clinicaltrials@seagen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Forero-Torres, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amitkumar Mehta
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudhir Manda
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine M Zain
Facility Name
California Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghassan Al-Jazayrly
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Cheng
Phone
415-885-3526
Email
michael.cheng@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Michael Cheng
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Completed
Facility Name
Maryland Oncology Hematology, P.A.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Wallmark
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Completed
Facility Name
Minnesota Oncology Hematology P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy G Larson
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Ansell
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Completed
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Completed
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Moskowitz
Facility Name
Wake Forest Baptist Medical Center / Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda L Gregson
Phone
336-716-2011
Email
agregson@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Ravi Paluri
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Completed
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Completed
Facility Name
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Completed
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason M Melear
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Cowey
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanisha Darko, MPH
Phone
713-834-6398
Email
TTBell@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ecaterina E Ileana-Dumbrava
Facility Name
Texas Oncology - Northeast Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald A Richards
Facility Name
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Kochenderfer
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander I Spira
Facility Name
Carbone Cancer Center / University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya V Uboha
Facility Name
University of Alberta / Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Completed
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Other
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Completed
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
State/Province
Other
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Ribrag
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
Other
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Curigliano
Facility Name
Policlinico Universitario Agostino Gemelli
City
Rome
State/Province
Other
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gennaro Daniele
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Other
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Garralda Cabanas
Facility Name
L'Institut Catala d'Oncologia
City
L'Hospitalet de Llobregat
State/Province
Other
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Oliva
Facility Name
HM Centro Integral Oncologico Clara Campal
City
Madrid
State/Province
Other
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jose de Miguel
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Other
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Fontana
Facility Name
The Royal Marsden Hospital (Surrey)
City
Sutton
State/Province
Other
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Minchom

12. IPD Sharing Statement

Learn more about this trial

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

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