Description:
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with pembrolizumab in
HER2 expressing or amplified advanced malignancies
Title
- Brief Title: A Study of SBT6050 Alone and in Combination With Pembrolizumab in Patients With Advanced HER2 Expressing Solid Tumors
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
SBT6050-101
- NCT ID:
NCT04460456
Conditions
- HER2 Positive Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| SBT6050 | | SBT6050 Monotherapy |
| pembrolizumab | | SBT6050 and pembrolizumab |
Purpose
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
Trial Arms
| Name | Type | Description | Interventions |
|---|
| SBT6050 Monotherapy | Experimental | Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1. | |
| SBT6050 and pembrolizumab | Experimental | 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. | |
Eligibility Criteria
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.
| 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 and 3 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: | Parts1 and 3 only |
| Measure: | Duration of response, defined as the time from date of first response (CR or PR) |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Parts 1 and 3 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, 2, 3 and 4 |
| Measure: | Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Cmax: Parts 1, 2, 3 and 4 |
| Measure: | Estimates of selected pharmacokinetics (PK ) parameters for SBT6050 |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | AUC: Parts 1, 2, 3 and 4 |
| 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 and 4 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
- Biliary tract cancer
- Head and neck cancer
- Urothelial cancer
- Endometrial cancer
- Pembrolizumab
- Anti-PD-1 mAb
Last Updated
May 3, 2021
