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Terminated • Phasen I, II • Stufe III, IV • Medical Oncology • Post-Menopausal • Interventionell

Folgendes wird aus ClinicalTrials.gov importiert:

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.

Breast Cancer

Studiendesign
Studientyp:

Interventional

Geschätzte Einschreibung:

2 Teilnehmer

Aktueller Studienbeginn:

8. Februar 2022

Zulassungskriterien
Alter für die Studie berechtigt:

18 - 999

Geschlechter für die Studie berechtigt:

both


Arms and Intervention
  • SBT6050

  • trastuzumab deruxtecan

  • tucatinib

  • trastuzumab

  • capecitabine

  • trastuzumab deruxtecan

Einschlusskriterien
  • advanced or metastatic her2-expressing (ihc 2+ or 3+) or her2-amplified solid tumors

  • measurable disease per the the response evaluation criteria in solid tumors (recist) version 1.1 criteria

  • tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows:

  • breast cancer and colorectal cancer (crc): archival biopsy tissue obtained after the last her2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy

  • gastric cancer and non-small-cell lung cancer (nsclc): archival biopsy tissue taken within the past 12 months and after completion of last her2-directed therapy, or a fresh biopsy

  • ecog performance status of 0 or 1

  • adequate hematologic, hepatic, renal, and cardiac function

Ausschlusskriterien
  • history of allergic reactions to certain components of study treatment therapies

  • untreated brain metastases

  • currently active (or history of) autoimmune disease

  • taking the equivalent of >10 mg / day of prednisone

  • taking a medication that moderately induces cyp2c, strongly inhibits cyp2c8, or interacts with both enzymes (cyp3a and cyp2c8)

  • uncontrolled or clinically significant interstitial lung disease (ild) / pneumonitis that requires systemic corticosteroid treatment or suspected ild / pneumonitis

  • hiv infection, active hepatitis b or hepatitis c infection

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

Terminated

Estimated Enrollment:

2

Last Updated:

10/30/2023


Hauptermittler

Naomi Hunder, MD


Studiensponsor

Silverback Therapeutics

Study Location (4)

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, United States

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