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Sponsor decision based on strategic re-alignment
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: SBT6290 | Experimental | SBT6290 every 3 weeks |
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| Part 2: SBT6290 | Experimental | SBT6290 every 3 weeks |
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| Part 3: SBT6290 + pembrolizumab | Experimental | SBT6290 plus pembrolizumab every 3 weeks |
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| Part 4: SBT6290 + pembrolizumab | Experimental | SBT6290 plus pembrolizumab every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBT6290 | Drug | Escalating doses by subcutaneous (SC) injection in 21-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to confirmed response, up to 1 year |
| Duration of Response for Participants With an Objective Response Rate: Part 1 and Part 3 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Angra, PharmD | Silverback Therapeutics, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38105538 | Derived | 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. |
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| SBT6290 | Drug | Dose expansion with the recommended Phase 2 dose (RP2D) by SC injection in 21-day cycles |
|
| pembrolizumab | Drug | 200 mg via intravenous (IV) injection in 21-day cycles |
|
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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. |
| 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. | 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. | 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). | 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). | Immediately before and after SBT6290 doses up to 2 years |
| Incidence of SBT6290 Antidrug Antibodies (ADA): All Parts | Number of participants positive for ADA. | Immediately before and after SBT6290 doses for up to 2 years |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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