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Brief Title: 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

INTRODUCTION

  • Org Study ID: SBT6290-101
  • Secondary ID: N/A
  • NCT ID: NCT05234606
  • Sponsor: Silverback Therapeutics

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.

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

  • Overall Status
    Withdrawn
  • Start Date
    March, 2022
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • 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

ELIGIBILITY

Key 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Natasha Angra, PharmD

Role: Study Director

Affiliation: Silverback Therapeutics, Inc.

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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