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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSBT6050 and trastuzumab deruxtecan

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 18, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Silverback Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Silverback Therapeutics
Interventions being studied: Drug: SBT6050; Drug: trastuzumab deruxtecan; Drug: tucatinib; Drug: trastuzumab; Drug: capecitabine; Drug: trastuzumab deruxtecan

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

HER2→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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: 1. Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy 2. 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

Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Massachusetts General HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2022. Always confirm current availability with the study team.

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