A Phase 1/2 interventional study of SBT6290 and SBT6290 in Urothelial Carcinoma, Triple Negative Breast Cancer and Non-small Cell Lung Cancer, sponsored by Silverback Therapeutics. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Silverback Therapeutics · Phase 1/2, Interventional, and Treatment
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.
This is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity, and preliminary antitumor activity of SBT6290 administered subcutaneously (SC) as a monotherapy and in combination with pembrolizumab in solid tumors associated with Nectin-4 expression. There are 4 parts to this study:
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
Browse Carcinoma studies →Silverback Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
SBT6290 every 3 weeks
Drug: SBT6290
SBT6290 every 3 weeks
Drug: SBT6290
SBT6290 plus pembrolizumab every 3 weeks
Drug: SBT6290 · Drug: pembrolizumab
SBT6290 plus pembrolizumab every 3 weeks
Drug: SBT6290 · Drug: pembrolizumab
Escalating doses by subcutaneous (SC) injection in 21-day cycles
Dose expansion with the recommended Phase 2 dose (RP2D) by SC injection in 21-day cycles
200 mg via intravenous (IV) injection in 21-day cycles
Also known as: KEYTRUDA
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years
Number of Participants With an Objective Response Rate: Part 1 and Part 3
Complete response and partial response as assessed by RECIST Version 1.1 Criteria.
Time frame: From enrollment to confirmed response, up to 1 year
Duration of Response for Participants With an Objective Response Rate: Part 1 and Part 3
The length of time from the participant's first complete response or partial response as assessed by RECIST Version 1.1 Criteria until disease progression or death.
Time frame: 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
Complete response, partial response, and stable disease as assessed by RECIST Version 1.1 Criteria.
Time frame: Up to at least 6 months after the first dose of SBT6290
Progression-free Survival: Part 2
Complete response, partial response, stable disease, and progressive disease as assessed by RECIST Version 1.1 Criteria.
Time frame: 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
Maximum concentration (Cmax).
Time frame: Immediately before and after SBT6290 doses up to 2 years
Estimates of Selected PK Parameters for SBT6290: All Parts
Area under the plasma concentration versus time curve (AUC).
Time frame: Immediately before and after SBT6290 doses up to 2 years
Incidence of SBT6290 Antidrug Antibodies (ADA): All Parts
Number of participants positive for ADA.
Time frame: Immediately before and after SBT6290 doses for up to 2 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Silverback Therapeutics