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

Titre officiel

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

Sommaire:

Cet essai portera sur un médicament appelé SEA-TGT (également connu sous le nom de SGN-TGT) afin de déterminer son innocuité pour les patients présentant une tumeur solide et un lymphome. Il étudiera le SEA-TGT pour déterminer ses effets secondaires. Un effet secondaire est tout ce que le médicament fait en dehors du traitement du cancer. Il déterminera également l’efficacité du SEA-TGT dans le traitement des tumeurs solides et des lymphomes.

L’étude comprendra trois volets. Le volet A de l’étude permettra de déterminer la dose de SEA-TGT à administrer aux patients. Le volet B utilisera la dose définie dans le volet A pour déterminer l’innocuité du SEA-TGT et son efficacité dans le traitement des tumeurs solides et des lymphomes. Le volet C étudiera l’efficacité du SEA-TGT associé au sasanlimab dans le traitement des tumeurs solides.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov