NCT05234606

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Silverback Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Urothelial Carcinoma
• Triple Negative Breast Cancer
• Non-small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Hormone Receptor-positive/HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SBT6290	Escalating doses by subcutaneous (SC) injection in 21-day cycles
DRUG	SBT6290	Dose expansion with the recommended Phase 2 dose (RP2D) by SC injection in 21-day cycles
DRUG	pembrolizumab	200 mg via intravenous (IV) injection in 21-day cycles

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2022-02-10
• Last updated: 2022-04-12

Regulatory

• FDA-regulated drug study