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BRIEF TITLE: SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

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


  • Org Study ID: SGNTGT-001
  • Secondary ID:
  • NCT ID: NCT04254107
  • NCT Alias:
  • Sponsor: Seagen Inc. - Industry
  • Source: 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 pembrolizumab works to treat solid tumors. Pembrolizumab is a drug that can be used to treat these types of cancer.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 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 - Time Frame: 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 - Time Frame: 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

Eligibility

Criteria:
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, ovarian cancer, or triple negative breast
cancer (TNBC)

- Lymphoma, 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)

- Participants with a histologically-confirmed advanced NSCLC or gastric carcinoma
meeting at least 1 of the following criteria:

- Unresectable locally-advanced or metastatic

- Relapsed, refractory, or progressive disease following at least 1 prior systemic
therapy

- Measurable disease by CT or magnetic resonance imaging (MRI) as defined by RECIST V1.1

- A representative 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 whose tumors are considered accessible and
appropriate in the opinion of the investigator.

- ECOG Performance Status score of 0 or 1

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.

- Known hypersensitivity to any excipient contained in the drug formulation of SEA-TGT

- 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.

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.

- 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

- 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.

- Uncontrolled diabetes mellitus

- 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
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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: Seagen Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

Locations

Facility Status Contact
University of Alabama at Birmingham
Birmingham, Alabama 35249
United States
Recruiting Jenny King

jpking@uabmc.edu
City of Hope National Medical Center
Duarte, California 91010-3000
United States
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Recruiting Ashley Moyer
507-284-0923
Haeska.Ashley@mayo.edu
Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting Lynn Freitas

lynn.freitas@providence.org
Hillman Cancer Center / University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting Barbara Stadterman
412-647-2811
stadtermanbm@upmc.edu
Institut Gustave Roussy
Villejuif, 94805
France
Recruiting Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Recruiting Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com
The Royal Marsden Hospital (Surrey)
Sutton, SM2 5PT
United Kingdom
Recruiting Seagen Trial Information Support
866-333-7436
clinicaltrials@seagen.com