臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 28, 2025
Last modified on	Jan. 28, 2025
Trial ID	jRCT2031240640

Scientific Title	An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination with Carboplatin and Platinum-based Anticancer Therapy
Public Title	Phase 1 Study of M9466 Combined with Carboplatin and Platinum-based Anticancer Therapy

Contact for Scientific Queries	Name	Suzuki Tomoya
	Affiliation	Merck Biopharma Co., Ltd.
	Address	1-3-1 Azabudai,Minato-ku, Tokyo
	Telephone	+81-80-5901-5395
	E-mail	MBJ_clinicaltrial_information@merckgroup.com
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	Merck Biopharma Co., Ltd.
	Address	1-3-1 Azabudai,Minato-ku, Tokyo
	Telephone	+81-3-6756-0800
	E-mail	MBJ_clinicaltrial_information@merckgroup.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 03, 2025
Actual date of first enrollment
Target sample size		54
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	-Module 1: Locally advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator (that is [i.e.] participants who have exhausted all standard of care options according to International Guidelines), which may convey clinical benefit from the combination treatment with M9466 and carboplatin and have not received more than 3 lines of prior anticancer therapy in the advanced/metastatic setting Module 2: Histologically or cytologically confirmed treatment-naive, de novo, extensive stage small cell lung cancer (ES-SCLC), who have no history of systemic treatment for the disease. Participant must be considered suitable to receive carboplatin, etoposide, and atezolizumab as first-line treatment for ES-SCLC -Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (<=) 1 (ECOG PS 2 eligible if considered related to SCLC tumor load in Module 2) -Have adequate hematological, hepatic, and renal function as defined in the protocol -Other protocol defined inclusion criteria could apply
	Exclusion Criteria	-Module 1: Persistence of AEs related to any prior treatments that have not recovered to Grade <= 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 unless AEs are clinically non-significant and /or stable on supportive therapy in the opinion of the Investigator (for example [e.g.] neuropathy or alopecia) -Module 2: Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years) -Participants with known brain metastases, except if clinically controlled, which is defined as individuals with CNS tumors that are asymptomatic and who do not require steroids for the treatment of CNS tumors -Life expectancy of less than (<) 3 months -Other protocol defined exclusion criteria could apply
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Advanced Solid Tumor
Intervention(s)		Experimental: Module 1 (Dose Finding): M9466 + Carboplatin Drug: M9466 -Participants will receive an escalating doses of M9466 orally in 21-day cycles until disease progression, intolerable toxicity, death, withdrawal of study or study consent, lost to follow-up, or end of study. -Other Names:HRS-1167 Drug: Carboplatin -Carboplatin will be administered intravenously on Day 1 of each 21-day cycle. Experimental: Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab Drug: Etoposide -Etoposide will be administered intravenously as per standard of care. Drug: Atezolizumab -Atezolizumab will be administered intravenously as per standard of care. Drug: M9446 -M9446 dose will be further investigated in Module 2 Part A of the study. -Other Names:HRS-1167 Drug: Carboplatin -Carboplatin will be administered intravenously as per standard of care. Experimental: Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab Drug: Etoposide -Etoposide will be administered intravenously as per standard of care. Drug: Atezolizumab -Atezolizumab will be administered intravenously as per standard of care. Drug: M9446 -M9446 recommended Dose for Expansion (RDE) will be further investigated in Module 2 Part B of the study. -Other Names:HRS-1167 Drug: Carboplatin -Carboplatin will be administered intravenously as per standard of care.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- Occurrence of TEAEs and treatment-related AEs - Occurrence of DLTs.
Secondary Outcome(s)

Primary Sponsor	Merck Biopharma Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	Chiken_CT@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Jan. 06, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06719973
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	USA/Spain/Korea/Canada