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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04460456




Registration number
NCT04460456
Ethics application status
Date submitted
29/06/2020
Date registered
7/07/2020
Date last updated
3/05/2021

Titles & IDs
Public title
A Study of SBT6050 Alone and in Combination With Pembrolizumab in Patients With Advanced HER2 Expressing Solid Tumors
Scientific 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
Secondary ID [1] 0 0
SBT6050-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SBT6050
Treatment: Drugs - pembrolizumab

Experimental: SBT6050 Monotherapy - Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.

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.


Treatment: Drugs: SBT6050
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2

Treatment: Drugs: pembrolizumab
400 mg IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of subjects experiencing dose limiting toxicities - Part 1 and 3 only
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
The incidence and severity of adverse events (AEs) and serious adverse events - Parts 1, 2, 3 and 4
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) - Part 2 and 4 only
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Duration of response, defined as the time from date of first response (CR or PR) - Part 2 and 4 only
Timepoint [4] 0 0
2 years
Secondary outcome [1] 0 0
Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR) - Parts1 and 3 only
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Duration of response, defined as the time from date of first response (CR or PR) - Parts 1 and 3 only
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Disease control rate, defined as CR, PR, or stable disease for at least 6 months - Parts 1, 2, 3 and 4
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 - Cmax: Parts 1, 2, 3 and 4
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 - AUC: Parts 1, 2, 3 and 4
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Incidence of antidrug antibodies (ADA) to SBT6050 - Parts 1 and 2
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Progression free survival - Part 2 and 4 only
Timepoint [7] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigative Site - Sydney
Recruitment hospital [2] 0 0
Investigative Site - Melbourne
Recruitment hospital [3] 0 0
Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Silverback Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in
HER2 expressing or amplified advanced malignancies
Trial website
https://clinicaltrials.gov/show/NCT04460456
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Naomi Hunder, MD
Address 0 0
Silverback Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
VP Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
(206) 456-2900
Fax 0 0
Email 0 0
ClinOps@Silverbacktx.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04460456