A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

INTRODUCTION

  • Org Study ID: SGNTGT-001
  • Secondary ID: N/A
  • NTC ID: NCT04254107
  • Sponsor: Seagen Inc.

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 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.

  • Overall Status
    Recruiting
  • Start Date
    May 29, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 1 - Timeframe: Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years

Primary Outcome 2 - Measure: Number of participants with laboratory abnormalities by grade

Primary Outcome 2 - Timeframe: Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years

Primary Outcome 3 - Measure: Number of participants with a DLT at each dose level

Primary Outcome 3 - Timeframe: Up to 21 days

CONDITION

  • 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

ELIGIBILITY

Monotherapy Inclusion Criteria (Parts A and B)
Histologically- or cytologically-confirmed advanced or metastatic malignancy, defined as:
One of the following disease indications:
Unresectable locally-advanced or metastatic 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 (≤24 months from screening). If archived tissue is not available, a fresh screening 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
Participants with a local histologically-confirmed advanced NSCLC TPS ≥50% and 1-49%, cutaneous melanoma (excluding acral or mucosal varieties), and HNSCC meeting at least 1 of the following criteria:
NSCLC: histological or cytological confirmed metastatic disease. Participants must have received no prior systemic regimen in the metastatic setting and no prior anti-PD-1 therapy allowed.

- HNSCC: histological or cytological confirmed metastatic disease. Participants must have received no prior systemic therapy in the metastatic setting and no prior exposure to anti-PD-L1 therapy.

- Cutaneous Melanoma: histological or cytological confirmed metastatic disease. Particpants must not have received anti-PD-1 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 (≤24 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Andres Forero-Torres, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Andres Forero-Torres, MD

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact
Facility: University of Alabama at Birmingham
Birmingham, Alabama 35249
United States
Status: Recruiting Contact: Contact
Jenny King
507-284-0923
jpking@uabmc.edu
Facility: Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85710
United States
Status: Recruiting Contact: Principal Investigator
Amitkumar Mehta
336-716-2011
Haeska.Ashley@mayo.edu
Facility: City of Hope National Medical Center
Duarte, California 91010-3000
United States
Status: Recruiting Contact: Principal Investigator
Sudhir Manda
503-215-6054
lynn.freitas@providence.org
Facility: Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota 55404
United States
Status: Recruiting Contact: Principal Investigator
Jasmine M Zain
503-215-5696
canrsrchstudies@providence.org
Facility: Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Principal Investigator
Timothy G Larson
412-647-2811
stadtermanbm@upmc.edu
Facility: Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact: Contact
Ashley Moyer
412-647-2811
davisc20@upmc.edu
Facility: Providence Portland Medical Center
Portland, Oregon 97213
United States
Status: Recruiting Contact: Principal Investigator
Stephen Ansell
866-333-7436
clinicaltrials@seagen.com
Facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Amanda L Gregson

Facility: Texas Oncology - Austin Midtown
Austin, Texas 78705
United States
Status: Recruiting Contact: Principal Investigator
Ravi Paluri

Facility: Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas 75246
United States
Status: Recruiting Contact: Contact
Lynn Freitas

Facility: MD Anderson Cancer Center / University of Texas
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Christina Lopez

Facility: Texas Oncology - Tyler
Tyler, Texas 75702
United States
Status: Recruiting Contact: Principal Investigator
Rachel E Sanborn

Facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Blacksburg, Virginia 24060
United States
Status: Recruiting Contact: Contact
Catherine Davis

Facility: Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Catherine Davis

Facility: Institut Gustave Roussy
Villejuif-Cedex-France, Other 94805
France
Status: Recruiting Contact: Principal Investigator
Diwakar Davar

Facility: Istituto Europeo di Oncologia
Milano, Other 20141
Italy
Status: Recruiting Contact: Principal Investigator
Jason M Melear

Facility: Hospital Universitario Vall d'Hebron
Barcelona, Other 08035
Spain
Status: Recruiting Contact: Principal Investigator
Carlos Becerra

Facility: The Royal Marsden Hospital (Surrey)
Sutton, Other SM2 5PT
United Kingdom
Status: Recruiting Contact: Contact
Tiantian Cai