Status:
WITHDRAWN
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
Lead Sponsor:
Silverback Therapeutics
Conditions:
Urothelial Carcinoma
Triple Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
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 subcut...
Eligibility Criteria
Inclusion
- Key
- Locally advanced or metastatic solid tumors associated associated with Nectin-4 expression (locally advanced or metastatic urothelial carcinoma, TNBC, NSCLC, SCCHN, and HR+/HER2- negative breast cancer)
- Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
- Tumor lesion amenable for biopsy available to submit for retrospective baseline testing of Nectin-4; archived tumor tissue may be acceptable depending upon study Part detailed criteria
- ECOG Performance Status of 0 or 1
- Adequate organ and marrow function Note: Other protocol-defined inclusion/exclusion criteria may apply.
- Key
Exclusion
- History of allergic reactions to certain components of study treatments
- Untreated brain metastases
- Currently active (or history of) autoimmune disease
- Taking the equivalent of \>10 mg / day of prednisone
- Uncontrolled or clinically significant interstitial lung disease (ILD)
- History of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living
- HIV infection, active hepatitis B or hepatitis C infection Note: Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05234606
Start Date
March 1 2022
End Date
March 31 2022
Last Update
April 12 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.