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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 : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Silverback Therapeutics

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE July 27, 2020
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • The proportion of subjects experiencing dose limiting toxicities [ Time Frame: 28 days ]
    Part 1 and 3 only
  • The incidence and severity of adverse events (AEs) and serious adverse events [ Time Frame: 2 years ]
    Parts 1, 2, 3 and 4
  • Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]
    Part 2 and 4 only
  • Duration of response, defined as the time from date of first response (CR or PR) [ Time Frame: 2 years ]
    Part 2 and 4 only
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • The proportion of subjects experiencing dose limiting toxicities [ Time Frame: 28 days ]
    Part 1 only
  • The incidence and severity of adverse events (AEs) and serious adverse events [ Time Frame: 2 years ]
    Parts 1 and 2
  • Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]
    Part 2 only
  • Duration of response, defined as the time from date of first response (CR or PR) [ Time Frame: 2 years ]
    Part 2 only
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]
    Parts1 and 3 only
  • Duration of response, defined as the time from date of first response (CR or PR) [ Time Frame: 2 years ]
    Parts 1 and 3 only
  • 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
  • Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 [ Time Frame: 2 years ]
    Cmax: Parts 1, 2, 3 and 4
  • Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 [ Time Frame: 2 years ]
    AUC: Parts 1, 2, 3 and 4
  • Incidence of antidrug antibodies (ADA) to SBT6050 [ Time Frame: 2 years ]
    Parts 1 and 2
  • Progression free survival [ Time Frame: 2 years ]
    Part 2 and 4 only
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: 2 years ]
    Part 1 only
  • Duration of response, defined as the time from date of first response (CR or PR) [ Time Frame: 2 years ]
    Part 1 only
  • Disease control rate, defined as CR, PR, or stable disease for at least 6 months [ Time Frame: 2 years ]
    Parts 1 and 2
  • Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 [ Time Frame: 2 years ]
    Cmax: Parts 1 and 2
  • Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 [ Time Frame: 2 years ]
    AUC: Parts 1 and 2
  • Incidence of antidrug antibodies (ADA) to SBT6050 [ Time Frame: 2 years ]
    Parts 1 and 2
  • Progression free survival [ Time Frame: 2 years ]
    Part 2 only
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SBT6050 Alone and in Combination With Pembrolizumab in Patients With Advanced HER2 Expressing Solid Tumors
Official Title  ICMJE 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
Brief Summary A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in HER2 expressing or amplified advanced malignancies
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 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HER2 Positive Solid Tumors
Intervention  ICMJE
  • Drug: SBT6050
    Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
  • Drug: pembrolizumab
    400 mg IV
Study Arms  ICMJE
  • Experimental: SBT6050 Monotherapy
    Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
    Intervention: Drug: SBT6050
  • 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.
    Interventions:
    • Drug: SBT6050
    • Drug: pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2020)
294
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2020)
210
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: VP Clinical Operations (206) 456-2900 ClinOps@Silverbacktx.com
Listed Location Countries  ICMJE Australia,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04460456
Other Study ID Numbers  ICMJE SBT6050-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Silverback Therapeutics
Study Sponsor  ICMJE Silverback Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Naomi Hunder, MD Silverback Therapeutics
PRS Account Silverback Therapeutics
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP