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Brief Title: A Study of SBT6050 Alone and in Combination With Pembrolizumab in Patients With Advanced HER2 Expressing Solid Tumors

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A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2

INTRODUCTION

  • Org Study ID: SBT6050-101
  • Secondary ID: N/A
  • NCT ID: NCT04460456
  • Sponsor: Silverback Therapeutics

BRIEF SUMMARY

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies

DETAILED DESCRIPTION

This study has 5 parts. Part 1 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing or amplified advanced malignancies.

Part 3 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.

Part 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.

  • Overall Status
    Unknown status
  • Start Date
    July 27, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: The proportion of subjects experiencing dose limiting toxicities

Primary Outcome 1 - Timeframe: 28 days

Primary Outcome 2 - Measure: The incidence and severity of adverse events (AEs) and serious adverse events

Primary Outcome 2 - Timeframe: 2 years

Primary Outcome 3 - Measure: Objective response rate

Primary Outcome 3 - Timeframe: 2 years

Primary Outcome 4 - Measure: defined as confirmed Complete Response (CR) or Partial Response (PR)

Primary Outcome 4 - Timeframe: 2 years

Primary Outcome 5 - Measure: Duration of response

Primary Outcome 5 - Timeframe: N/A

Primary Outcome 6 - Measure: defined as the time from date of first response (CR or PR)

Primary Outcome 6 - Timeframe: N/A

CONDITION

  • HER2 Positive Solid Tumors

ELIGIBILITY

Inclusion Criteria:
* Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor

- * Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)

- * Measurable disease per RECIST 1.1

- * Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months

- * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- * Adequate hematologic, hepatic, and cardiac function
Exclusion Criteria:
* History of allergic reactions to certain components of SBT6050 or similar drugs

- * Untreated brain metastases

- * Active autoimmune disease or a documented history of autoimmune disease or syndrome

- * Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection

- * Additional protocol defined inclusion/exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Naomi Hunder, MD

Role: Study Director

Affiliation: Silverback Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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