NCT07908667
A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer
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Record History
All 2 versions: 2 with changes below.
- Notable Recruitment opened
- Study sites: 0 to 1
- Primary and study completion dates: Aug 6, 2030 to Jul 30, 2030
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to approximately 24 months
Incidence of Dose Limiting Toxicities (DLTs)
Timeframe: 21 days
Frequency of dose interruptions and reductions
Timeframe: Up to approximately 24 months
Dose intensity
Timeframe: Up to approximately 24 months
Secondary (8)
Maximum serum concentration (Cmax) of TRB191
Time to reach maximum serum concentration (Tmax) of TRB191
Arean under the serum concentration-time curve (AUC) of TRB191
Number of participants with anti-drug antibodies (ADA)
Overall Response Rate (ORR) per RECIST v1.1
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Disease Control Rate (DCR) per RECIST v1.1
Duration of Response (DOR) per RECIST v1.1
Progression-Free Survival (PFS) per RECIST v1.1
Arms and interventions
TRB191 single agentExperimental
Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer.
Drugs: TRB191
Sites
1 site in 1 country
- Novartis Investigative SiteTel Aviv, Israel