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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460456
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Silverback Therapeutics

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 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


Arm Intervention/treatment
Experimental: SBT6050 Drug: SBT6050
Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.




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

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

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

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


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

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

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

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

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

  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 only



Information from the National Library of Medicine

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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+) 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.

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, 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
Sponsors and Collaborators
Silverback Therapeutics
Investigators
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Study Director: Naomi Hunder, MD Silverback Therapeutics
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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: August 11, 2020
Last Verified: July 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
Additional relevant MeSH terms:
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Neoplasms