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

A Phase 2 open-label basket study to evaluate the efficacy and safety of orally administered reversible tyrosine kinase inhibitor BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations - panSOHO

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011240072

Enrollment

111

Registered

2025-02-25

Start date

2025-03-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic or unresectable locally advanced solid tumors with HER2-activating mutations

Interventions

Sevabertinib (BAY2927088) tablet, oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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; breast cancer and 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
- Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Australia, Canada, China, Denmark, France, Italy, Japan, South Korea, Spain, United States

Contacts

Public Contactcontact Dedicated

Bayer Yakuhin, Ltd.

byl_ct_contact@bayer.com+81-6-6133-6363

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026