A Phase 2 basket study of BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations by Bayer Yakuhin, Ltd.

JRCT ID: jRCT2011240072

Registered date:25/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metastatic or unresectable locally advanced solid tumors with HER2-activating mutations
• Date of first enrollment: 25/02/2025
• Target sample size: 111
• Countries of recruitment: Australia,Japan,Canada,Japan,China,Japan,Denmark,Japan,Spain,Japan,France,Japan,Italy,Japan,South Korea,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): BAY2927088 tablet, oral

Outcome(s)

• Primary Outcome: - Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR

Secondary Outcome

- Duration of response (DOR) per RECIST 1.1 as assessed by BICR
- Time to response (TTR) per RECIST 1.1 as assessed by BICR
- ORR per RECIST 1.1 as assessed by the investigator
- Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
- DCR 12 weeks per RECIST 1.1 as assessed by BICR
- Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
- 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
- Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
- DOR per RECIST 1.1 as assessed by the investigator
- TTR per RECIST 1.1 as assessed by the investigator
- Overall survival (OS)
- 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
- Time to deterioration in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 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)
2. Participant must be >= 18 years of age or over the legal age of consent
3. Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
4. Documented activating HER2 mutation
5. At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria

Exclude criteria

1. Primary diagnosis of non-small cell lung cancer (NSCLC)
2. Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
3. Active brain metastases
4. Uncontrolled, severe, intercurrent illness

Related Information

• Primary Sponsor: Myoishi Masafumi
• Secondary ID(s): NCT06760819