臨床研究等提出・公開システム

Date of registration	Jan. 08, 2026
Last modified on	June. 02, 2026
Trial ID	jRCT2031250629

Scientific Title	A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)
Public Title	A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

Contact for Scientific Queries	Name	Paranthaman Nindhana
	Affiliation	Summit Therapeutics Inc.
	Address	601 Brickell Key Drive, Suite 1000, Miami, FL
	Telephone	1-415-794-0266
	E-mail	Nindhana.Paranthaman@smmttx.com
Contact for Public Queries	Name	Taira Hironori
	Affiliation	Syneos Health Japan K.K.
	Address	12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-90-1790-0160
	E-mail	hironori.taira@syneoshealth.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 18, 2026
Actual date of first enrollment		April. 10, 2026
Target sample size		50
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. An Eastern Cooperative Oncology Organization Group (ECOG) performance status score of 0 or 1. 2. Expected life expectancy is at least 6 months. 3. Patients with histologically or cytologically confirmed metastatic CRC, not amenable to curative resection. 4. No prior systemic therapy for metastatic CRC. 5. At least one measurable tumor lesion according to RECIST v1.1 that is amenable to repeated accurate measurements.
	Exclusion Criteria	1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease 2. Known BRAF V600E mutant status 3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction. 4. Ascites requiring paracentesis within last 30 days. 5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and any other therapy based on the mechanism of action of tumor immunity or angiogenesis. 6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). 7. Resectable oligometastastic only disease, with multidisciplinary plan for complete resection of all disease.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Metastatic Colorectal Cancer
Intervention(s)		Patients randomly assigned in a 1:1 ratio to the 2 treatment groups: - Group A: ivonescimab (20 mg/kg, every 2 weeks) + mFOLFOX6 (on Days 1, 2 of a 2-week treatment cycle) for 8 cycles followed by maintenance with ivonescimab, 5-FU, and levofolinate - Group B: bevacizumab (5 mg/kg, every 2 weeks) + mFOLFOX6 (on Days 1, 2 of a 2-week treatment cycle) for 8 cycles followed by maintenance with bevacizumab, 5-FU, and levofolinate
Primary Outcome(s)		Progression-free survival (PFS) as assessed by blinded Independent Radiological Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome(s)		- OS - ORR and DOR as assessed by IRRC based on RECIST v1.1 - Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results. - Pharmacokinetic profile: Serum concentrations of ivonescimab in patients at different time points after ivonescimab administration. - Immunogenicity assessment: Number and percentage of patients with detectable anti-ivonescimab antibody.

Primary Sponsor	Summit Therapeutics Inc.

Name of Certified Review Board	National Cancer Ctr IRB #2-J
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-3542-2511
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan, Tokyo
Telephone	+81-11-706-7061
E-Mail	tiken@med.hokudai.ac.jp
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Hiroshima University Hospital Institutional Review Board
Address	Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima, Tokyo
Telephone	+81-82-257-5596
E-Mail	hugcp@hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Chiba Cancer Center Institutional Review Board
Address	666-2 Nitona-cho, Chuo-ku, Chiba-City, Chiba, Tokyo
Telephone	+81-43-264-5431
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Tohoku University Hospital Institutional Review Board
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan, Tokyo
Telephone	+81-22-717-7000
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	National Hospital Organization Shikoku Cancer Center Institutional Review Board
Address	160 Kou, Minamiumemoto-machi, Matsuyama-shi, Ehime, Japan, Tokyo
Telephone	+81-89-999-1111
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	CANCER INSTITUTE HOSPITAL OF JFCR Institutional Review Board
Address	3-8-31 Ariake, Koto-ku, Tokyo, Tokyo
Telephone	+81-3-3520-0111
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Gifu University Hospital Institutional Review Board
Address	1-1 Yanagido, Gifu-shi, Gifu, Tokyo
Telephone	+81-58-230-6000
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Shizuoka Cancer Ctr IRB#2
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka , Tokyo
Telephone	+81-55-989-5222
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Kanagawa Cancer Center Institutional Review Board
Address	2-3-2, Nakao, Asahi, Yokohama, Kanagawa, Tokyo
Telephone	+81-45-520-2222
E-Mail	chiken-jimu4@kcch.jp
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Osaka Prefectural Hospital Organization Osaka International Cancer Institute Institutional Review Board
Address	3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka, Tokyo
Telephone	+81-6-6945-1181
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Aichi Cancer Center Institutional Review Board
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan, Tokyo
Telephone	+81-52-762-6111
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Toyama University Hospital Drug Acceptance Research Review Board
Address	2630 Sugitani, Toyama-shi, Toyama, Tokyo
Telephone	+81-76-434-7151
E-Mail	chiken@med.u-toyama.ac.jp
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	The Institutional Review Board, The University of Osaka Hospital
Address	2-15 Yamadaoka, Suita, Osaka 565-0871, Japan, Tokyo
Telephone	+81-6-6879-5111
E-Mail	jim-chiken@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	St. Marianna University Group Institutional Review Board
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Tokyo
Telephone	+81-44-977-8111
Approval Status	Approval
Date of approval	Dec. 22, 2025

Name of Certified Review Board	Saitama Prefectural Cancer Center IRB
Address	780 Komuro, Ina-machi, Kitaadachi-gun, Saitama, Tokyo
Telephone	+81-48-722-1111
Approval Status	Approval
Date of approval	Dec. 22, 2025

Plan to share IPD	No

Secondary ID(s)	NCT07228832
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	USA/Canada/Mexico/Belgium/Czechia/France/Germany/Hungary/Italy/Poland/Serbia/Spain/United Kingdom

History of Changes

No	Publication date
5	June. 02, 2026	(this page)	Changes
4	April. 16, 2026	Detail	Changes
3	April. 15, 2026	Detail	Changes
2	Feb. 09, 2026	Detail	Changes
1	Jan. 08, 2026	Detail

List of change history