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(22752) 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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517419-62-00
Acronym
22752
Enrollment
37
Registered
2025-02-13
Start date
2025-02-28
Completion date
Unknown
Last updated
2026-01-16

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

Conditions

Advanced solid tumors, HER2 mutation

Brief summary

Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)

Detailed description

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. 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)

Interventions

Sponsors

Bayer Consumer Care AG, Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)

Secondary

MeasureTime 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. Number of participants who discontinue study treatment due to an AE, Time to deterioration in EORTC QLQ-C30 physical functioning domai

Countries

Denmark, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026