Drugs / BMS-986310
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06570031 | Nov 2021 → Apr 2026 | hormone receptor-positive breast cancer | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06542731 | Jun 2021 → Sep 2026 overdue | non-small cell lung carcinoma | Ono Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06538207 | Jan 2021 → Oct 2024 | malignant pancreatic neoplasm | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06547385 | Jan 2021 → Oct 2027 expected | colorectal cancer | Ono Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03661632 | Sep 2018 → Nov 2019 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03155061 | Apr 2017 → Mar 2028 expected | — | Ono Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT06948448 | Nov 2025 → Feb 2028 expected | colorectal cancer | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06256328 | Jan 2024 → Oct 2025 overdue | gastric cancer | Ono Pharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07818070 | Feb 2027 → Jan 2031 expected | esophageal adenocarcinoma, gastric cancer, gastroesophageal cancer | Ono Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Ono Pharmaceutical Co., Ltd. | Results Ono Pharma Announces Oral Presentation of New Data from Phase 2 Clinical Study of ONO-4578 (EP4 antagonist) in Certain Gastric Cancers at the ASCO 2026 Annual Meeting ono-pharma.com ↗
The ONO-4578 group demonstrated a statistically significant improvement of PFS compared to the placebo with a median PFS of 9.0 months in the ONO-4578 group and 6.9 months in the placebo group (HR, 0.67; 90% CI, 0.48–0.92; P = 0.040). |
| 2025-10-09 | Ono Pharmaceutical Co., Ltd. | Results Ono Announces ONO-4578 (EP4 antagonist) in Combination with Opdivo and Chemotherapy Met the Primary Endpoint in a Phase 2 Clinical Trial in Patients with Certain Gastric Cancer ono-pharma.com ↗
In the trial, ONO-4578 in combination with Opdivo and chemotherapy demonstrated a statistically significant prolongation of progression-free survival (PFS) compared with placebo in combination with Opdivo and chemotherapy. |
All press releases naming this drug 4 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BMS-986310 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03661632 ↗ |
| Known as | ONO-4578 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03155061 ↗ |
| Action | Inhibit | “ONO-4578, a highly selective EP4 antagonist” PMID 36082616 ↗ Nov 2022 |
| Modality | Small molecule | — CHEMBL5314911 ↗ |