Study Stopped
Sponsor decision based on strategic re-alignment
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2022
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 12, 2022
April 1, 2022
1 month
January 13, 2022
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Dose Limiting Toxicities: Part 1 and Part 3
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0.
Up to 28 days after the first dose of SBT6290
Number of Participants With Treatment-emergent Adverse Events: All Parts
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0.
From enrollment to 30 days after the last dose of SBT6290, up to 2 years
Number of Participants With an Objective Response Rate: Part 2 and Part 4
Complete response and partial response as assessed by RECIST Version 1.1 Criteria.
From enrollment to confirmed response, up to 1 year
Duration of Response for Participants With an Objective Response Rate: Part 2 and Part 4
Complete response and partial response as assessed by RECIST Version 1.1 Criteria.
From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years
Secondary Outcomes (7)
Number of Participants With an Objective Response Rate: Part 1 and Part 3
From enrollment to confirmed response, up to 1 year
Duration of Response for Participants With an Objective Response Rate: Part 1 and Part 3
From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years
Rate of Disease Control for Participants: All Parts
Up to at least 6 months after the first dose of SBT6290
Progression-free Survival: Part 2
From first dose of SBT6290 until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years
Estimates of Selected PK Parameters for SBT6290: All Parts
Immediately before and after SBT6290 doses up to 2 years
- +2 more secondary outcomes
Study Arms (4)
Part 1: SBT6290
EXPERIMENTALSBT6290 every 3 weeks
Part 2: SBT6290
EXPERIMENTALSBT6290 every 3 weeks
Part 3: SBT6290 + pembrolizumab
EXPERIMENTALSBT6290 plus pembrolizumab every 3 weeks
Part 4: SBT6290 + pembrolizumab
EXPERIMENTALSBT6290 plus pembrolizumab every 3 weeks
Interventions
Escalating doses by subcutaneous (SC) injection in 21-day cycles
200 mg via intravenous (IV) injection in 21-day cycles
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic solid tumors associated associated with Nectin-4 expression (locally advanced or metastatic urothelial carcinoma, TNBC, NSCLC, SCCHN, and HR+/HER2- negative breast cancer)
- Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
- Tumor lesion amenable for biopsy available to submit for retrospective baseline testing of Nectin-4; archived tumor tissue may be acceptable depending upon study Part detailed criteria
- ECOG Performance Status of 0 or 1
You may not qualify if:
- History of allergic reactions to certain components of study treatments
- Untreated brain metastases
- Currently active (or history of) autoimmune disease
- Taking the equivalent of \>10 mg / day of prednisone
- Uncontrolled or clinically significant interstitial lung disease (ILD)
- History of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Xu F, Xu K, Fan L, Li X, Liu Y, Yang F, Zhu C, Guan X. Estrogen receptor beta suppresses the androgen receptor oncogenic effects in triple-negative breast cancer. Chin Med J (Engl). 2024 Feb 5;137(3):338-349. doi: 10.1097/CM9.0000000000002930. Epub 2023 Dec 15.
PMID: 38105538DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natasha Angra, PharmD
Silverback Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 10, 2022
Study Start
March 1, 2022
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
April 12, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share