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-

Login to view timeline

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

Login to view more data

100 Translational Medicine associated with ONO-4578

Login to view more data

100 Patents (Medical) associated with ONO-4578

Login to view more data

100 Deals associated with ONO-4578

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

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 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
Advanced cancer	Preclinical	BE	Bristol Myers Squibb Co.	11 Sep 2018
Advanced cancer	Preclinical	CA	Bristol Myers Squibb Co.	11 Sep 2018

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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	(ngetyqkior) = 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 qynwkkbtve (jvbzlgtmea )	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)	wvgsnszjjv(bwfsoclaya) = No patient died due to TEAEs opyxzroyse (rxzelqtohd )	Positive	20 Jun 2024
JPRN-JapicCTI-173496 \| NCT03155061 (Pubmed) Manual	Phase 1	Solid tumor	31	ONO-4578	(saxoqkwdze) = cbtfmspida godcokyfau (whvlfgrkji )	Positive	09 Sep 2022
JPRN-JapicCTI-173496 \| NCT03155061 (Pubmed) Manual	Phase 1	Solid tumor	31	ONO-4578+Nivolumab	(ypqzmjtneo) = oqkoqjzdhl nrvcvtollk (ueirwmqhpv ) View more	Positive	09 Sep 2022