臨床研究等提出・公開システム

Date of registration	Feb. 01, 2022
Last modified on	April. 03, 2026
Trial ID	jRCT2051210165

Scientific Title	A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-fluorouracil/oxaliplatin and bevacizumab in metastatic colorectal cancer patients
Public Title	A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-fluorouracil/oxaliplatin and bevacizumab in metastatic colorectal cancer patients (Sensible mCRC)

Contact for Scientific Queries	Name	Tawara Shunsuke
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Clinical Trial Information Contact for
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Suspended

Anticipated date of first enrollment		Feb. 28, 2022
Actual date of first enrollment		Mar. 24, 2022
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	18 years of age or older Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum * ECOG performance status of 0 or 1 * The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study * Able to sufficiently understand the clinical study and give written informed consent
	Exclusion Criteria	History of major hemorrhage High risk of hemorrhage * History of other malignancies * Active ulcer * Patients using anti-coagulants and fibrinolytic drugs * Active Hepatitis B, or known HBs antigen positive * Prior treatment history with thrombomodulin alfa * Administration of another investigational medicinal product within 30 days prior to randomization * Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period * Patients otherwise deemed as inappropriate to participate in the study by the Investigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		metastatic colorectal cancer
Intervention(s)		Drug: Thrombomodulin alfa (ART-123), IV Drug: Bevacizumab, IV Drug: Oxaliplatin, IV Drug: Levofolinate/ Folinate calcium, IV Drug: 5-fluorouracil, IV
Primary Outcome(s)		Safety endpoints: AEs, Bleeding eventsDLTs, Laboratory tests, Vital signs (body temperature, systolic blood pressure, diastolic blood pressure, heart rate), Anti-ART-123 antibodies and neutralizing antibodies PK endpoints: Plasma concentration of thrombomodulin, Plasma concentration of 5-FU, Plasma concentration of oxaliplatin, Serum concentration of bevacizumab

Primary Sponsor	Veloxis Pharmaceuticals, Inc.

Secondary Sponsor

Name of Certified Review Board	Sano Hospital Institutional Review Board
Address	2-5-1, Shimizugaoka,Tarumi-ku,Kobe city, Hyogo
Telephone	+81-78-785-1000
Approval Status	Approval
Date of approval	Nov. 25, 2021

Plan to share IPD	No

Secondary ID(s)	NCT05251727
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	the United States

History of Changes

No	Publication date
7	April. 03, 2026	(this page)	Changes
6	Aug. 09, 2024	Detail	Changes
5	Nov. 19, 2023	Detail	Changes
4	April. 08, 2022	Detail	Changes
3	Mar. 11, 2022	Detail	Changes
2	Feb. 05, 2022	Detail	Changes
1	Feb. 01, 2022	Detail

List of change history