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

Phase 1

Terminated

• 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
• Interventions: Drug: SEA-TGT; Drug: sasanlimab; Drug: brentuximab vedotin

• Registration Number: NCT04254107
• Lead 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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-05-29
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with a dose-limiting toxicity (DLT) at each dose level	Up to 21 days	To be summarized using descriptive statistics
Number of participants with adverse events (AEs)	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	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	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	To be summarized using descriptive statistics

Secondary Outcome Measures

Name	Time	Method
Complete response (CR) rate	Up to approximately 3 years	Proportion of participants with CR per the participant's specific tumor response criteria
Objective Response Rate (ORR)	Up to approximately 3 years	Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumor response criteria
Area under the concentration-time curve (AUC)	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	To be summarized using descriptive statistics.
Time to maximum concentration (tmax)	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	To be summarized using descriptive statistics.
Duration of objective response	Up to approximately 3 years	Time from first response to the first documentation of disease progression or death due to any cause
Maximum concentration (Cmax)	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	To be summarized using descriptive statistics.
Trough concentration (Ctrough)	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	To be summarized using descriptive statistics.
Duration of CR	Up to approximately 3 years	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	Up to approximately 3 years	Time from first dose to the first documentation of disease progression or death due to any cause
Duration of overall survival	Up to approximately 3 years	Time from start of study treatment to the date of death due to any cause
Number of participants with antidrug antibodies (ADA)	Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years	To be summarized using descriptive statistics.

Trial Locations

Locations (36)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

California Research Institute; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies; 🇺🇸 San Francisco, California, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Maryland Oncology Hematology, P.A.; 🇺🇸 Rockville, Maryland, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Minnesota Oncology Hematology P.A.; 🇺🇸 Minneapolis, Minnesota, United States

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