Recruiting • Phasen I, II • Stufe III, IV • HER2 negativ • Medical Oncology • Post-Menopausal • Interventionell

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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

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 associated with Nectin-4 expression.

Beschreibung

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

Studiendesign

Zulassungskriterien

Arms and Intervention

• SBT6290

• SBT6290

• pembrolizumab

Einschlusskriterien

• 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

Ausschlusskriterien

• 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.