A Phase 2 basket study of BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations by Bayer Yakuhin, Ltd. (panSOHO)
- Conditions
- Metastatic or unresectable locally advanced solid tumors with HER2-activating mutations
- Registration Number
- jRCT2011240072
- Lead Sponsor
- Bayer Yakuhin, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 111
- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; other solid tumor cancer, excluding NSCLC)
- Participant must be >= 18 years of age or over the legal age of consent
- Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
- Documented activating HER2 mutation
- At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria
- Primary diagnosis of non-small cell lung cancer (NSCLC)
- Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
- Active brain metastases
- Uncontrolled, severe, intercurrent illness
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - - Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) per RECIST 1.1 as assessed by BICR Duration of response (DOR) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR Progression-free survival (PFS) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
DCR >=12 weeks per RECIST 1.1 as assessed by the investigator >=12 weeks Disease control rate (DCR) at >=12 weeks per RECIST 1.1 as assessed by the investigator
Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
DOR per RECIST 1.1 as assessed by the investigator Duration of response (DOR) per RECIST 1.1 as assessed by the investigator
TTR per RECIST 1.1 as assessed by the investigator Time to response (TTR) per RECIST 1.1 as assessed by the investigator
Overall survival (OS) Overall survival (OS)
Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL) Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QoL)
Time to response (TTR) per RECIST 1.1 as assessed by BICR Time to response (TTR) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
ORR per RECIST 1.1 as assessed by the investigator Objective Response Rate (ORR) per RECIST 1.1 as assessed by the investigator
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR Disease control rate (DCR) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
DCR 12 weeks per RECIST 1.1 as assessed by BICR 12 weeks Disease control rate (DCR) at 12 weeks per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an AE Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an adverse event (AE)
Time to deterioration in EORTC QLQ-C30 physical functioning domain score Time to deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) physical functioning domain score
Change from baseline in EORTC QLQ-C30 physical functioning domain score Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) physical functioning domain score