C4251003- A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511481-37-00

Acronym

SGNTUC-019

Enrollment

Registered

2024-04-09

Start date

2021-07-12

Completion date

Unknown

Last updated

2025-06-17

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

Conditions

Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

Brief summary

Confirmed objective response rate (ORR; confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment

Detailed description

Disease control rate (DCR; confirmed CR or PR, or stable disease) per investigator assessment, Duration of response (DOR; confirmed CR or PR) per investigator Assessment Progression-free survival (PFS) per investigator assessment, Overall survival (OS), Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Type, incidence, and severity of laboratory abnormalities, Frequency of treatment interruptions, dose reductions, and treatment discontinuations due to AEs, Other relevant safety variables including AEs of special interest (AESIs)

Interventions

DRUGTUKYSA 150 mg film-coated tablets

DRUGHerceptin 150 mg powder for concentrate for solution for infusion

DRUGFaslodex 250 mg solution for injection.

DRUGFulvestrant Mylan 250 mg solution for injection in prefilled syringe

DRUGTUKYSA 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Confirmed objective response rate (ORR; confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment	—

Secondary

Measure	Time frame
Disease control rate (DCR; confirmed CR or PR, or stable disease) per investigator assessment, Duration of response (DOR; confirmed CR or PR) per investigator Assessment Progression-free survival (PFS) per investigator assessment, Overall survival (OS), Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Type, incidence, and severity of laboratory abnormalities, Frequency of treatment interruptions, dose reductions, and treatment discontinuations due to AEs, Other relevant safety variables including AEs of special interest (AESIs)	—

Measure

Time frame

—

Countries

Belgium, Germany, Spain

Outcome results

None listed

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