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Oncology Clinical Trial Finder
Breast Cancer
Location

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.

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Recruiting

Estimated Enrollment:

225

Last Updated:

10/30/2023


Trial Contact

Clinical Trials Operations

ClinOps@Silverbacktx.com

206 456-2900


Principal Investigator

Natasha Angra, PharmD


Trial Sponsor

Silverback Therapeutics

Study Location (5)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mount Sinai Medical Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of California San Diego

San Diego, California, United States

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