Recruiting • Phase I, II • Stage III, IV • HER2 negative • Medical Oncology • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
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.
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
Breast Cancer
Study Design
Study type:
Interventional
Estimated enrollment:
225 participant
Actual study start date:
March 20, 2022
Eligibility Criteria
Ages eligible for study:
18 - 999
Sexes eligible for study:
both
Arms and Intervention
SBT6290
SBT6290
pembrolizumab
Inclusion criteria
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 criteria
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.