臨床研究等提出・公開システム

Japanese

Date of registration	June. 25, 2022
Last modified on	Feb. 07, 2024
Trial ID	jRCT2031220162

Scientific Title	A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-overexpressing gastric/gastroesophageal junction adenocarcinoma (ASPEN-06)
Public Title	A Study of Evorpacept (ALX148) in Patients with Advanced Gastric Cancer (ASPEN-06)

Contact for Scientific Queries	Name	Fanning Philip
	Affiliation	ALX Oncology Inc.
	Address	323 Allerton Ave, South San Francisco, CA, 94080, USA
	Telephone	1-650-466-7125
	E-mail	info@alxoncology.com
Contact for Public Queries	Name	Clinical trial contact
	Affiliation	ICON Clinical Research GK
	Address	Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan
	Telephone	+81-6-4560-2001
	E-mail	ICONCR-Chiken@iconplc.com

Recruitment status	Suspended

Anticipated date of first enrollment		July. 01, 2022
Actual date of first enrollment		Aug. 23, 2022
Target sample size		54
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line) -Adequate Bone Marrow Function. -Adequate Renal and Liver Function. -Adequate Performance Status.
	Exclusion Criteria	-Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids. -Prior treatment with any anti-CD47 or anti-SIRP alpha agent. -Prior treatment with ramucirumab.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		gastric/gastroesophageal junction adenocarcinoma
Intervention(s)		ALX148 30 mg/kg Q2W as an intravenous infusion on Days 1 and 15 of a 28-day cycle. Trastuzumab will be administered at an initial dose of 6 mg/kg administered as an intravenous infusion, followed by 4 mg/kg intravenous infusion administered on Days 1 and 15 of a 28-day cycle. Ramucirumab will be administered at a dose of 8 mg/kg Days 1 and 15 of a 28-day cycle by intravenous infusion. Paclitaxel will be administered at a dose of 80 mg/m^2 Days 1, 8, and 15 of a 28-day cycle by intravenous infusion.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Phase 2: -Percentage of patients with objective response per RECIST 1.1 Phase 3: -Overall Survival
Secondary Outcome(s)

Primary Sponsor	ALX Oncology Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Ctr IRB #2-J
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail
Approval Status	Approval
Date of approval	May. 16, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05002127
Issuing Authority	ClinicalTrials.gov

Secondary ID(s)	2021-001008-14
Issuing Authority	EudraCT

Countries of Recruitment（Except Japan）	BELGIUM/CZECH REPUBLIC/FRANCE/ITALY/SINGAPORE/SOUTH KOREA/SPAIN/TAIWAN/UNITED KINGDOM/UNITED STATES

History of Changes

No	Publication date
6	Feb. 07, 2024	(this page)	Changes
5	Jan. 26, 2024	Detail	Changes
4	Nov. 07, 2023	Detail	Changes
3	April. 29, 2023	Detail	Changes
2	July. 30, 2022	Detail	Changes
1	June. 25, 2022	Detail

List of change history