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

Official Title

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

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 sasanlimab works to treat solid tumors.

Trial Description

Primary Outcome Measures :

• Number of participants with adverse events (AEs) 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
  To be summarized using descriptive statistics
• Number of participants with a DLT at each dose level
  To be summarized using descriptive statistics

• Objective Response Rate (ORR)
  
• Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumour response criteria
• Complete response (CR) rate
  Proportion of participants with CR per the participant's specific tumour response criteria
• Duration of objective response
  Time from first response to the first documentation of disease progression or death due to any cause
• Duration of CR
  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
  Time from first dose to the first documentation of disease progression or death due to any cause
  
• Duration of overall survival
  Time from start of study treatment to the date of death due to any cause
  
• Area under the concentration-time curve (AUC)
  To be summarized using descriptive statistics.
  
• Time to maximum concentration (tmax)
  To be summarized using descriptive statistics.
  
• Maximum concentration (Cmax)
  To be summarized using descriptive statistics.
  
• Trough concentration (Ctrough)
  To be summarized using descriptive statistics.
  
• Number of participants with antidrug antibodies (ADA)
  To be summarized using descriptive statistics.

View this trial on ClinicalTrials.gov