Delving into the Latest Updates on ONO-4578 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

+ [1]

Target

EP4

Mechanism

EP4 antagonists(Prostanoid EP4 receptor antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Gastrooesophageal junction cancerHER2 negative Gastric CancerBreast cancer recurrent+ [13]

Inactive Indication-

Originator Organization

Ono Pharmaceutical Co., Ltd.

Active Organization

Ono Pharmaceutical Co., Ltd.

Inactive Organization

Bristol Myers Squibb Co.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Start Date06 Dec 2023

Sponsor / Collaborator

Ono Pharmaceutical Co., Ltd.

JPRN-jRCT2031210364 / Not yet recruitingPhase 1IIT

ONO-4578-06: Phace I , Open-label, non-blind, first-line endocrine therapy with ONO-4578 and standard treatment letrozole and CDK4 /6 inhibitors (palbociclib or abemaciclib) in patients with metastatic or recurrent postmenopausal hormone receptor-positive HER2-negative breast cancer

Start Date09 Nov 2021

Sponsor / Collaborator-

NCT06570031 / Active, not recruitingPhase 1

ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer

This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.

Start Date09 Nov 2021

Sponsor / Collaborator

Ono Pharmaceutical Co., Ltd.

100 Clinical Results associated with ONO-4578

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100 Translational Medicine associated with ONO-4578

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100 Patents (Medical) associated with ONO-4578

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100 Deals associated with ONO-4578

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrooesophageal junction cancer	Phase 2	JP	Ono Pharmaceutical Co., Ltd.	06 Dec 2023
Gastrooesophageal junction cancer	Phase 2	TW	Ono Pharmaceutical Co., Ltd.	06 Dec 2023
Gastrooesophageal junction cancer	Phase 2	KR	Ono Pharmaceutical Co., Ltd.	06 Dec 2023
HER2 negative Gastric Cancer	Phase 2	KR	Ono Pharmaceutical Co., Ltd.	06 Dec 2023
HER2 negative Gastric Cancer	Phase 2	JP	Ono Pharmaceutical Co., Ltd.	06 Dec 2023
HER2 negative Gastric Cancer	Phase 2	TW	Ono Pharmaceutical Co., Ltd.	06 Dec 2023
Advanced cancer	Phase 2	BE	Bristol Myers Squibb Co.	11 Sep 2018
Advanced cancer	Phase 2	US	Bristol Myers Squibb Co.	11 Sep 2018
Advanced Malignant Solid Neoplasm	Phase 1	JP	Ono Pharmaceutical Co., Ltd.	10 Apr 2017
Metastatic Solid Tumor	Phase 1	JP	Ono Pharmaceutical Co., Ltd.	10 Apr 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCT2031200215 (ONO-4578-02, ESMO_GI2024) Manual	Phase 1	Metastatic Colorectal Carcinoma \|	34	ONO-4578 +NIV	(ldaxbqreiq) = 28 (82.4%) with grade ≥3 and 20 (58.8%) with serious TEAEs; 15 patients (44.1%) discontinued of any study treatment due to TEAEs. No patient died due to TEAEs gyzzyiuzhv (scpihjfvjm )	Positive	30 Jun 2024
JPRN-jRCT2031200215 (ONO-4578-02, ESMO_GI2024)	Phase 1	Metastatic Colorectal Carcinoma PD-L1 combined positive score (CPS) \| M1/M2 macrophages	34	ONO-4578 (40 mg) + Nivolumab (360 mg) + Chemotherapy (capecitabine, oxaliplatin, bevacizumab)	klkvqfegjw(bcbkfmrbou) = No patient died due to TEAEs edkvydumzo (kiviamgtgi )	Positive	20 Jun 2024
JPRN-JapicCTI-173496 \| NCT03155061 (Pubmed) Manual	Phase 1	Solid tumor	31	ONO-4578	(houcympkbi) = yrpefjgefy cohrlapddb (kaijyixlqw )	Positive	09 Sep 2022
JPRN-JapicCTI-173496 \| NCT03155061 (Pubmed) Manual	Phase 1	Solid tumor	31	ONO-4578+Nivolumab	(ynaoxhatrq) = bpywbcehhs uwzdfthfxk (ejwyozlwdj ) View more	Positive	09 Sep 2022