A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
NCT05234606 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2022-04-12
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.
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
- 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
-
200 mg via intravenous (IV) injection in 21-day cycles
Sponsors & Collaborators
-
Silverback Therapeutics
lead INDUSTRY
Principal Investigators
-
Natasha Angra, PharmD · Silverback Therapeutics, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2022-03-31
- Completion
- 2022-03-31
- FDA Drug
- Yes
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