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Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

NCT ID: NCT03155061

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced or Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A (Dose Escalation Part): ONO-4578 monotherapy

ONO-4578 specified dose on specified days in advanced or metastatic solid tumors

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

ONO-4578 specified dose on specified days

Part B: ONO-4578 in combination with ONO-4538

ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

ONO-4578 specified dose on specified days

ONO-4538

Intervention Type DRUG

ONO-4538 specified dose on specified days

Part C (Expansion Part): ONO-4578 in combination with ONO-4538

ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

ONO-4578 specified dose on specified days

ONO-4538

Intervention Type DRUG

ONO-4538 specified dose on specified days

Part D (Expansion Part): ONO-4578 in combination with ONO-4538

ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

ONO-4578 specified dose on specified days

ONO-4538

Intervention Type DRUG

ONO-4538 specified dose on specified days

Interventions

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ONO-4578

ONO-4578 specified dose on specified days

Intervention Type DRUG

ONO-4538

ONO-4538 specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients with severe complication
* Patients with multiple primary cancers
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Aichi Clinical Site 1

Nagoya, Aichi-ken, Japan

Site Status

Aichi Clinical Site 2

Toyoake, Aichi-ken, Japan

Site Status

Chiba Clinical Site 1

Kashiwa, Chiba, Japan

Site Status

Ehime Clinical Site1

Matsuyama, Ehime, Japan

Site Status

Gunma Clinical Site 1

Ōta, Gunma, Japan

Site Status

Hokkaido Clinical Site 1

Sapporo, Hokkaido, Japan

Site Status

Iwate Clinical Site 1

Yahaba-cho, Iwate, Japan

Site Status

Kanagawa Clinical Site 2

Sagamihara, Kanagawa, Japan

Site Status

Kanagawa Clinical Site 1

Yokohama, Kanagawa, Japan

Site Status

Osaka Clinical Site 2

Hirakata, Osaka, Japan

Site Status

Osaka Clinical Site 3

Sakai, Osaka, Japan

Site Status

Osaka Clinical Site 4

Takatsuki, Osaka, Japan

Site Status

Saitama Clinical Site 2

Hidaka, Saitama, Japan

Site Status

Saitama Clinical Site 1

Ina-machi, Saitama, Japan

Site Status

Shizuoka Clinical Site 1

Nagaizumi-Cho, Shizuoka, Japan

Site Status

Tokyo Clinical Site 1

Chuo-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 4

Itabashi-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 2

Koto-ku, Tokyo, Japan

Site Status

Tokyo Clinical Site 3

Shinjyuku-ku, Tokyo, Japan

Site Status

Fukuoka Clinical Site 1

Fukuoka, , Japan

Site Status

Fukuoka Clinical Site 2

Fukuoka, , Japan

Site Status

Osaka Clinical Site 1

Osaka, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 40618725 (View on PubMed)

Iwasa 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.

Reference Type DERIVED
PMID: 36082616 (View on PubMed)

Other Identifiers

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jRCT2080223441

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONO-4578-01

Identifier Type: -

Identifier Source: org_study_id

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