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

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ClinicalTrials.gov Identifier: NCT04460456
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Silverback Therapeutics

Study Description
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Brief Summary:
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in HER2 expressing or amplified advanced malignancies

Condition or disease Intervention/treatment Phase
HER2 Positive Solid Tumors Drug: SBT6050 Drug: pembrolizumab Phase 1

Detailed Description:

This study has 4 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 2. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Expressing HER2
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SBT6050 Monotherapy
Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
 Drug: SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
Experimental: SBT6050 and pembrolizumab
Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.
 Drug: SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2

Drug: pembrolizumab
400 mg IV


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of subjects experiencing dose limiting toxicities [ Time Frame: 28 days ]
    Part 1 and 3 only

  2. The incidence and severity of adverse events (AEs) and serious adverse events [ Time Frame: 2 years ]
    Parts 1, 2, 3 and 4

  3. Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]
    Part 2 and 4 only

  4. Duration of response, defined as the time from date of first response (CR or PR) [ Time Frame: 2 years ]
    Part 2 and 4 only


Secondary Outcome Measures :
  1. Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]
    Parts1 and 3 only

  2. Duration of response, defined as the time from date of first response (CR or PR) [ Time Frame: 2 years ]
    Parts 1 and 3 only

  3. Disease control rate, defined as CR, PR, or stable disease for at least 6 months [ Time Frame: 2 years ]
    Parts 1, 2, 3 and 4

  4. Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 [ Time Frame: 2 years ]
    Cmax: Parts 1, 2, 3 and 4

  5. Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 [ Time Frame: 2 years ]
    AUC: Parts 1, 2, 3 and 4

  6. Incidence of antidrug antibodies (ADA) to SBT6050 [ Time Frame: 2 years ]
    Parts 1 and 2

  7. Progression free survival [ Time Frame: 2 years ]
    Part 2 and 4 only


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460456


Contacts
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Contact: VP Clinical Operations (206) 456-2900 ClinOps@Silverbacktx.com

Locations
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United States, Massachusetts
Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Investigative Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Investigative Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Investigative Site Recruiting
Houston, Texas, United States, 77030
Investigative Site Recruiting
San Antonio, Texas, United States, 78229
Australia, New South Wales
Investigative Site Recruiting
Sydney, New South Wales, Australia, 2109
Australia, Victoria
Investigative Site Recruiting
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Investigative Site Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Silverback Therapeutics
Investigators
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Study Director: Naomi Hunder, MD Silverback Therapeutics
More Information
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Responsible Party: Silverback Therapeutics
ClinicalTrials.gov Identifier: NCT04460456    
Other Study ID Numbers: SBT6050-101
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silverback Therapeutics:
HER2
ERBB2
Immunotherapy
Gastric Cancer
Gastroesophageal junction
Breast Cancer
Triple Negative Breast Cancer
Stomach Cancer
Colorectal Cancer
Gastrointestinal Cancer
Non-Small Cell Lung Cancer
 Monoclonal antibody
TLR8
TLR8 agonist
Antibody drug conjugate
Biliary tract cancer
Head and neck cancer
Urothelial cancer
Endometrial cancer
Pembrolizumab
Anti-PD-1 mAb
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents