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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 weeks
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.
Time frame: 0 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 escalation cohorts.
Time frame: 18 weeks
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8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
1000 mg/m2 PO BID for 14 days of each 21-day cycle
6.4 mg/kg by IV infusion in 21-day cycles
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.
Time frame: 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.
Time frame: 0 weeks