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A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors

Non-small Cell Lung Cancer Clinical Trial

Official title:
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression

Clinical Trial Summary

This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression.

Clinical Trial Description

This is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity, and preliminary antitumor activity of SBT6290 administered subcutaneously (SC) as a monotherapy and in combination with pembrolizumab in solid tumors associated with Nectin-4 expression. There are 4 parts to this study: - Part 1: A dose escalation of SBT6290 monotherapy - Part 2: Tumor-specific expansion cohorts evaluating SBT6290 monotherapy administered at the recommended phase 2 dose (RP2D) identified in Part 1 - Part 3: A dose escalation of SBT6290 in combination with pembrolizumab - Part 4: An expansion cohort of SBT6290 in combination with pembrolizumab administered at the RP2D identified in Part 3 for the combination ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05234606
Study type Interventional
Source Silverback Therapeutics
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date March 2022
Completion date March 31, 2022
View Details
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