A Safety Study of SEA-TGT in Patients With Advanced Cancer

Overview

About this study

This trial will look at a drug called SGN-TGT to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-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 SGN-TGT works to treat solid tumors and lymphomas. The study will have three groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SGN-TGT with a PD-(L)1 inhibitor works to treat solid tumors and lymphomas. PD-(L)1 inhibitors are drugs that can be used to treat these types of cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 or gastric carcinoma
      • Lymphoma, including:

        • Classical Hodgkin lymphoma (cHL)
        • Diffuse large B-cell lymphoma (DLBCL)
        • Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
    • Relapsed, refractory or progressive disease, specifically:

      • Solid tumors: Following at least 1 prior systemic therapy and for which no further standard therapy is available at the time of enrollment, and with the specific prior therapies as listed below.

        • NSCLC: Participants must have received platinum-based therapy. Participants must have received at least 1 PD-1- or PD-L1-targeted therapy, unless clinically contraindicated. Participants must have received mutation-targeted therapies as appropriate. These agents may have been administered either as single agents or in combination.
        • Gastric Carcinoma: Participants must have received prior platinum and fluoropyrimidine-based chemotherapy, unless clinically contraindicated. If appropriate, participants must also have received ramucirumab. In addition, participants should have received HER2/neu-targeted therapy if appropriate. Participants with PD-L1 expressing tumors (CPS scores of 1 or greater) must have received appropriate anti-PD-1 or anti-PD-L1 therapy unless clinically contraindicated.
      • 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 SGN-TGT (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 SGN-TGT (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 SGN-TGT (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 SGN-TGT (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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Ansell, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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More information

Publications

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Study Results Summary

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Supplemental Study Information

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Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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