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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05091528
Other study ID # SBT6050-201
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date February 8, 2022
Est. completion date July 7, 2022

Study information

Verified date July 2022
Source Silverback Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date July 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 1. Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy 2. Gastric cancer and non-small-cell lung cancer (NSCLC): archival biopsy tissue taken within the past 12 months and after completion of last HER2-directed therapy, or a fresh biopsy - ECOG Performance Status of 0 or 1 - Adequate hematologic, hepatic, renal, and cardiac function Exclusion Criteria: - History of allergic reactions to certain components of study treatment therapies - Untreated brain metastases - Currently active (or history of) autoimmune disease - Taking the equivalent of >10 mg / day of prednisone - Taking a medication that moderately induces CYP2C, strongly inhibits CYP2C8, or interacts with both enzymes (CYP3A and CYP2C8) - Uncontrolled or clinically significant interstitial lung disease (ILD) / pneumonitis that requires systemic corticosteroid treatment or suspected ILD / pneumonitis - HIV infection, active hepatitis B or hepatitis C infection

Study Design


Intervention

Drug:
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
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
trastuzumab deruxtecan
6.4 mg/kg by IV infusion in 21-day cycles

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Silverback Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 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. 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. 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. 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. 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. 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. 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. 0 weeks
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