NCT04254107

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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
• Triple Negative Breast Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	SEA-TGT	Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle
DRUG	sasanlimab	Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle
DRUG	brentuximab vedotin	Given by IV on Day 1 of each 21-day cycle

Timeline

• Start date: 2020-05-29
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-02-05
• Last updated: 2025-02-10

Locations

36 sites across 6 countries: United States, Canada, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study