Drugs / adagloxad simolenin
adagloxad simolenin
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT03608878 | Apr → Dec 2019 | hepatocellular carcinoma | Chang Gung Memorial Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT01516307 | Dec 2011 → Aug 2016 | breast cancer | OBI Pharma, Inc | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT03562637 | Dec 2018 → Dec 2025 overdue | triple-negative breast carcinoma | OBI Pharma, Inc | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-04-23 | OBI Pharma, Inc | Results OBI-822 Completes Second Interim Analysis of Phase III Trial OBI Announces Trial Termination, Refocuses Resources on ADC Development obipharma.com ↗
Following their review of the second interim data, the DSMB convened and recommended that the trial be terminated. |
| 2017-01-25 | OBI Pharma, Inc | Regulatory China FDA approves Clinical Trial Application for Adagloxad Simolenin Phase III Study obipharma.com ↗
On 24 January 2017, OBI Pharma, Inc. (4174) received formal approval from the China Food and Drug Administration (CFDA) to conduct a proposed phase III clinical trial for Adagloxad Simolenin (OBI-822, formerly known as OPT-822)/OBI-821. |
| 2016-07-27 | OBI Pharma, Inc | Results Quick Takes on Promising New Approaches to Treating Breast Cancer obipharma.com ↗
The primary synthroidnews.net was not met, but we saw a very provocative result in IgG/IgM responders…. |
| 2016-06-05 | OBI Pharma, Inc | Results OBI Pharma Presents Data for Novel Investigational OBI-822/OBI-821 in Patients with Metastatic Breast Cancer at the 2016 American Society of Clinical Oncology Annual Meeting obipharma.com ↗
The study did not meet the primary efficacy end point of progression-free survival (PFS) in patients with late stage metastatic breast cancer. |
| 2016-05-19 | OBI Pharma, Inc | Results OBI’s Abstract at ASCO 2016: Randomized Phase 2/3 Trial of Active Immunotherapy With OPT-822/OPT-821 in Patients With Metastatic Breast Cancer obipharma.com ↗
No difference was observed in PFS (HR=0.96 [95%CI 0.74-1.25] p=0.77); or in interim OS (HR=0.79 [95%CI 0.51-1.22] p=0.29). |
| 2016-02-21 | OBI Pharma, Inc | Results OBI Pharma Reports Topline Results from OBI-822/821 Randomized Controlled Phase 2/3 Clinical Trial in Patients with Metastatic Breast Cancer obipharma.com ↗
Based on the data available to date, the study (Protocol Number OPT-822-001) did not meet the primary efficacy end point of progression-free survival. |
| 2012-08-08 | OBI Pharma, Inc | Regulatory Breast Cancer New Drug: OBI-822/821 received Taiwan FDA Approval for entering Phase III trial obipharma.com ↗
Breast Cancer New Drug:OBI-822/821 received Taiwan FDA Approval for entering Phase III trial |
All press releases naming this drug 16 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Adagloxad simolenin | “PURPOSE: This randomized, double-blind, placebo-controlled, parallel-group, phase II trial assessed the efficacy and safety of adagloxad simolenin (OBI-822; a Globo H epitope...” PMID 32718986 ↗ Jul 2020 |
| Known as | AdaSim | “In a phase II study, adagloxad simolenin (AdaSim), a synthetic Globo H conjugate vaccine administered with adjuvant OBI-821, was shown to induce IgM and IgG anti-Globo H...” PMID 36268941 ↗ Oct 2022 |
| Known as | Globo H-KLH | “to form Adagloxad simolenin (OBI-822) (Globo H-KLH)” NCT03608878 ↗ |
| Known as | OBI-822 | “PURPOSE: This randomized, double-blind, placebo-controlled, parallel-group, phase II trial assessed the efficacy and safety of adagloxad simolenin (OBI-822; a Globo H epitope...” PMID 32718986 ↗ Jul 20202“The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High...” NCT03562637 ↗ “Adagloxad simolenin (OBI-822) is a glyco-conjugated protein comprised of a carbohydrate tumor antigen.” NCT03608878 ↗ |
| Known as | OPT-822 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707279 ↗ |
| Modality | Vaccine | “Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821” PMID 32718986 ↗ Jul 2020 |