臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 25, 2025
Last modified on	Feb. 25, 2025
Trial ID	jRCT2011240072

Scientific Title	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)
Public Title	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)

Contact for Scientific Queries	Name	Myoishi Masafumi
	Affiliation	Bayer Yakuhin, Ltd.
	Address	2-4-9 Umeda, Kita-ku, Osaka, Osaka
	Telephone	+81-6-6133-6363
	E-mail	byl_ct_contact@bayer.com
Contact for Public Queries	Name	Dedicated contact
	Affiliation	Bayer Yakuhin, Ltd.
	Address	2-4-9 Umeda, Kita-ku, Osaka, Osaka
	Telephone	+81-6-6133-6363
	E-mail	byl_ct_contact@bayer.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 25, 2025
Actual date of first enrollment
Target sample size		111
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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; 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	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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Metastatic or unresectable locally advanced solid tumors with HER2-activating mutations
Intervention(s)		BAY2927088 tablet, oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Secondary Outcome(s)		- 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)

Primary Sponsor	Bayer Yakuhin, Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hokkaido Uneiversity Hospital Institutional Review Board
Address	Nishi 5, Kita 14jo, Kitaku, Sapporo, Hokkaido, Hokkaido
Telephone	+81-11-706-7061
E-Mail	tiken@med.hokudai.ac.jp
Approval Status	Approval
Date of approval	Jan. 21, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06760819
Issuing Authority	clinicaltrials.gov

Countries of Recruitment（Except Japan）	Australia/Canada/China/Denmark/Spain/France/Italy/South Korea/United States