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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04460456




Registration number
NCT04460456
Ethics application status
Date submitted
29/06/2020
Date registered
7/07/2020
Date last updated
30/06/2022

Titles & IDs
Public title
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects 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 PD-1 Inhibitors 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
Treatment: Drugs - Cemiplimab

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.

Experimental: SBT6050 and cemiplimab - SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.


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

Treatment: Drugs: pembrolizumab
400 mg IV

Treatment: Drugs: Cemiplimab
350 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
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
The incidence and severity of adverse events (AEs) and serious adverse events
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)
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)
Timepoint [4] 0 0
2 years
Secondary outcome [1] 0 0
Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)
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)
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
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Estimates of selected pharmacokinetics (PK ) parameters for SBT6050
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Incidence of antidrug antibodies (ADA) to SBT6050
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Progression free survival
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
Sex
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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital Clinical Trials Unit - Sydney
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Breast Cancer Research Centre - WA - 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
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Korea, Republic of
State/province [6] 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 PD-1 inhibitors in
HER2 expressing or amplified advanced malignancies
Trial website
https://clinicaltrials.gov/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04460456