Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
2 other identifiers
interventional
183
1 country
22
Brief Summary
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2017
Longer than P75 for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2017
CompletedStudy Start
First participant enrolled
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
June 5, 2025
June 1, 2025
9.9 years
March 17, 2017
June 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
Through study completion, an average of 1 year
Secondary Outcomes (3)
Maximum observed serum concentration(Cmax)
Up to Cycle 1 (each cycle is 28 days)
Area Under the blood concentration-time Curve(AUC)
Up to Cycle 1 (each cycle is 28 days)
Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538
Up to Cycle 1 (each cycle is 28 days)
Study Arms (4)
Part A (Dose Escalation Part): ONO-4578 monotherapy
EXPERIMENTALONO-4578 specified dose on specified days in advanced or metastatic solid tumors
Part B: ONO-4578 in combination with ONO-4538
EXPERIMENTALONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
Part C (Expansion Part): ONO-4578 in combination with ONO-4538
EXPERIMENTALONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
Part D (Expansion Part): ONO-4578 in combination with ONO-4538
EXPERIMENTALONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
Interventions
ONO-4578 specified dose on specified days
ONO-4538 specified dose on specified days
Eligibility Criteria
You may qualify if:
- Advanced or metastatic solid tumors (Part A, B)
- Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
- Unresectable, advanced or recurrent colorectal cancer(Part D)
- Life expectancy of at least 3 months
- Patients with ECOG performance status 0 or 1
You may not qualify if:
- Patients with severe complication
- Patients with multiple primary cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Aichi Clinical Site 1
Nagoya, Aichi-ken, Japan
Aichi Clinical Site 2
Toyoake, Aichi-ken, Japan
Chiba Clinical Site 1
Kashiwa, Chiba, Japan
Ehime Clinical Site1
Matsuyama, Ehime, Japan
Gunma Clinical Site 1
Ōta, Gunma, Japan
Hokkaido Clinical Site 1
Sapporo, Hokkaido, Japan
Iwate Clinical Site 1
Yahaba-cho, Iwate, Japan
Kanagawa Clinical Site 2
Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site 1
Yokohama, Kanagawa, Japan
Osaka Clinical Site 2
Hirakata, Osaka, Japan
Osaka Clinical Site 3
Sakai, Osaka, Japan
Osaka Clinical Site 4
Takatsuki, Osaka, Japan
Saitama Clinical Site 2
Hidaka, Saitama, Japan
Saitama Clinical Site 1
Ina-machi, Saitama, Japan
Shizuoka Clinical Site 1
Nagaizumi-Cho, Shizuoka, Japan
Tokyo Clinical Site 1
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site 4
Itabashi-ku, Tokyo, Japan
Tokyo Clinical Site 2
Koto-ku, Tokyo, Japan
Tokyo Clinical Site 3
Shinjyuku-ku, Tokyo, Japan
Fukuoka Clinical Site 1
Fukuoka, Japan
Fukuoka Clinical Site 2
Fukuoka, Japan
Osaka Clinical Site 1
Osaka, Japan
Related Publications (2)
Kawazoe A, Yamaguchi K, Hamaguchi T, Narita Y, Boku S, Oshima T, Hara H, Hamamoto Y, Ishido K, Esaki T, Hosaka H, Yasui H, Koeda K, Nishina T, Tsuji Y, Fukagawa T, Goto M, Oki E, Sugimoto N, Matsuoka H, Yokoyama F, Yoshida T, Yoshida K, Oshima Y, Iwasa S. ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. Cancer Sci. 2025 Sep;116(9):2523-2536. doi: 10.1111/cas.70130. Epub 2025 Jul 6.
PMID: 40618725DERIVEDIwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4.
PMID: 36082616DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2017
First Posted
May 16, 2017
Study Start
April 19, 2017
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share