Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decision based on strategic re-alignment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBT6050 + T-DXd (5.4 mg/kg) | Experimental | SBT6050 plus trastuzumab deruxtecan |
|
| SBT6050 + T-DXd (6.4 mg/kg) | Experimental | SBT6050 plus trastuzumab deruxtecan |
|
| SBT6050 + Tucatinib + Trastuzumab + Capecitabine | Experimental | SBT6050 plus tucatinib, trastuzumab, and capecitabine |
|
| SBT6050 + Tucatinib + Trastuzumab | Experimental | SBT6050 plus tucatinib and trastuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBT6050 | Drug | Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Dose Limiting Toxicities | Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. | 21 days |
| Number of Participants With Treatment-emergent Adverse Events | Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. | 18 weeks |
| Number of Participants With Laboratory Abnormalities | Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. | 18 weeks |
| Number of Participants With an Objective Response Rate | Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose expansion cohorts. | 0 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts. | 0 weeks |
| Number of Participants With an Objective Response Rate |
Not provided
Inclusion Criteria:
Advanced or metastatic HER2-expressing (IHC 2+ or 3+) or HER2-amplified solid tumors
Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
Tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows:
ECOG Performance Status of 0 or 1
Adequate hematologic, hepatic, renal, and cardiac function
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naomi Hunder, MD | Silverback Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SBT6050 + T-DXd (5.4 mg/kg) | SBT6050 plus trastuzumab deruxtecan SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 5.4 mg/kg by intravenous (IV) infusion in 21-day cycles |
| FG001 | SBT6050 + T-DXd (6.4 mg/kg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| trastuzumab deruxtecan | Drug | 5.4 mg/kg by intravenous (IV) infusion in 21-day cycles |
|
|
| tucatinib | Drug | 300 mg by mouth (PO) twice daily (BID) |
|
|
| trastuzumab | Drug | 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles |
|
|
| capecitabine | Drug | 1000 mg/m2 PO BID for 14 days of each 21-day cycle |
|
|
| trastuzumab deruxtecan | Drug | 6.4 mg/kg by IV infusion in 21-day cycles |
|
|
Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose escalation cohorts. |
| 18 weeks |
| Duration of Response for Participants With an Objective Response Rate | 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. This outcome measure applies to all participants. | 0 weeks |
| Proportion of Participants With Clinical Benefit Rate | Complete response, partial response, or durable stable disease as assessed by RECIST Version 1.1 Criteria. This outcome measure applied only to participants in the dose expansion cohorts. | 0 weeks |
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles |
| FG002 | SBT6050 + Tucatinib + Trastuzumab + Capecitabine | SBT6050 plus tucatinib, trastuzumab, and capecitabine SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles capecitabine: 1000 mg/m2 PO BID for 14 days of each 21-day cycle |
| FG003 | SBT6050 + Tucatinib + Trastuzumab | SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants who received at least one dose of SBT6050.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SBT6050 + T-DXd (6.4 mg/kg) | SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles |
| BG001 | SBT6050 + Tucatinib + Trastuzumab | SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Primary Tumor Type | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Therapy Regimens | Number | Number of therapy regimens |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Dose Limiting Toxicities | Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. | Participants who were enrolled and treated with at least 1 dose of SBT6050. | Posted | Count of Participants | Participants | 21 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-emergent Adverse Events | Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. | Participants who were enrolled and treated with at least 1 dose of SBT6050. | Posted | Count of Participants | Participants | 18 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities | Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts. | Participants who were enrolled and treated with at least 1 dose of SBT6050. | Posted | Count of Participants | Participants | 18 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With an Objective Response Rate | Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose expansion cohorts. | No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor. | Posted | 0 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events | Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts. | No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor. | Posted | 0 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Objective Response Rate | Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose escalation cohorts. | Participants who were enrolled and treated with at least 1 dose of SBT6050. | Posted | Count of Participants | Participants | 18 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response for Participants With an Objective Response Rate | 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. This outcome measure applies to all participants. | Data not captured; study was terminated by Sponsor. | Posted | 0 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Clinical Benefit Rate | Complete response, partial response, or durable stable disease as assessed by RECIST Version 1.1 Criteria. This outcome measure applied only to participants in the dose expansion cohorts. | No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor. | Posted | 0 weeks |
|
|
18 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SBT6050 + T-DXd (6.4 mg/kg) | SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | SBT6050 + Tucatinib + Trastuzumab | SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles | 0 | 1 | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
Early termination leading to small numbers of participants analyzed.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Silverback Therapeutics, Inc. | 206-456-2900 | info@silverbacktx.com |
| Jul 18, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
| C000705452 | tucatinib |
| D000068878 | Trastuzumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Colorectal cancer |
|
|
|
|