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

NCT05091528 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-08-18

Study results available
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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.

Conditions

Interventions

DRUG

SBT6050

Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

DRUG

trastuzumab deruxtecan

5.4 mg/kg by intravenous (IV) infusion in 21-day cycles

DRUG

tucatinib

300 mg by mouth (PO) twice daily (BID)

DRUG

trastuzumab

8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles

DRUG

capecitabine

1000 mg/m2 PO BID for 14 days of each 21-day cycle

DRUG

trastuzumab deruxtecan

6.4 mg/kg by IV infusion in 21-day cycles

Sponsors & Collaborators

  • Silverback Therapeutics

    lead INDUSTRY

Principal Investigators

  • Naomi Hunder, MD · Silverback Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2022-07-07
Completion
2022-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05091528 on ClinicalTrials.gov