Clinical Trials /

A Study of SBT6050 in Patients With Advanced HER2 Expressing Solid Tumors

NCT04460456

Description:

A first-in-human (FIH) study using SBT6050 in HER2 expressing advanced malignancies

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of SBT6050 in Patients With Advanced HER2 Expressing Solid Tumors
  • Official Title: A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 in Subjects With Advanced Solid Tumors Expressing HER2

Clinical Trial IDs

  • ORG STUDY ID: SBT6050-101
  • NCT ID: NCT04460456

Conditions

  • HER2 Positive Solid Tumors

Interventions

DrugSynonymsArms
SBT6050SBT6050

Purpose

A first-in-human (FIH) study using SBT6050 in HER2 expressing advanced malignancies

Detailed Description

      This study has 2 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 advanced malignancies.
    

Trial Arms

NameTypeDescriptionInterventions
SBT6050Experimental
  • SBT6050

Eligibility Criteria

        Inclusion Criteria:

          -  Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) 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

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The proportion of subjects experiencing dose limiting toxicities
Time Frame:28 days
Safety Issue:
Description:Part 1 only

Secondary Outcome Measures

Measure:Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)
Time Frame:2 years
Safety Issue:
Description:Part 1 only
Measure:Duration of response, defined as the time from date of first response (CR or PR)
Time Frame:2 years
Safety Issue:
Description:Part 1 only
Measure:Disease control rate, defined as CR, PR, or stable disease for at least 6 months
Time Frame:2 years
Safety Issue:
Description:Parts 1 and 2
Measure:Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
Time Frame:2 years
Safety Issue:
Description:Cmax: Parts 1 and 2
Measure:Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
Time Frame:2 years
Safety Issue:
Description:AUC: Parts 1 and 2
Measure:Incidence of antidrug antibodies (ADA) to SBT6050
Time Frame:2 years
Safety Issue:
Description:Parts 1 and 2
Measure:Progression free survival
Time Frame:2 years
Safety Issue:
Description:Part 2 only

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Silverback Therapeutics

Trial Keywords

  • 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

Last Updated

July 10, 2020