A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies
Overview
- Phase
- Phase 1
- Intervention
- SEA-TGT
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Seagen Inc.
- Enrollment
- 133
- Locations
- 36
- Primary Endpoint
- Number of participants with a dose-limiting toxicity (DLT) at each dose level
- Status
- Terminated
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SEA-TGT Monotherapy (Parts A and B)
SEA-TGT
Intervention: SEA-TGT
SEA-TGT + sasanlimab Combination Therapy (Part C)
SEA-TGT + sasanlimab
Intervention: SEA-TGT
SEA-TGT + sasanlimab Combination Therapy (Part C)
SEA-TGT + sasanlimab
Intervention: sasanlimab
SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
SEA-TGT + brentuximab vedotin
Intervention: SEA-TGT
SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
SEA-TGT + brentuximab vedotin
Intervention: brentuximab vedotin
Outcomes
Primary Outcomes
Number of participants with a dose-limiting toxicity (DLT) at each dose level
Time Frame: Up to 21 days
To be summarized using descriptive statistics
Number of participants with adverse events (AEs)
Time Frame: 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
Time Frame: Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
To be summarized using descriptive statistics
Secondary Outcomes
- Objective Response Rate (ORR)(Up to approximately 3 years)
- Area under the concentration-time curve (AUC)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Time to maximum concentration (tmax)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Complete response (CR) rate(Up to approximately 3 years)
- Duration of objective response(Up to approximately 3 years)
- Maximum concentration (Cmax)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Trough concentration (Ctrough)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Duration of CR(Up to approximately 3 years)
- Duration of progression-free survival(Up to approximately 3 years)
- Duration of overall survival(Up to approximately 3 years)
- Number of participants with antidrug antibodies (ADA)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)