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

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

Brief Summary

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.

Beschreibung

Studiendesign

Zulassungskriterien

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