Drugs / OBI-821
OBI-821
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06490198 | Jul 2024 → Jul 2026 overdue | cholangiocarcinoma | Chang Gung Memorial Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT02310464 | Dec 2015 → Dec 2020 | breast cancer, colorectal cancer, gastric cancer, lung cancer | OBI Pharma, Inc | Completed | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT00911560 | May 2009 → May 2027 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | Missed primary |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT05442060 | Jul 2022 → Dec 2025 overdue | non-small cell lung carcinoma | OBI Pharma, Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT05376423 | Jun 2022 → Dec 2024 | esophageal cancer | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04936529 | Aug 2021 → Jun 2027 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| 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 32 trials | ||||||
| Phase 3 | NCT03562637 | Dec 2018 → Dec 2025 overdue | triple-negative breast carcinoma | OBI Pharma, Inc | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00693342 | — | fallopian tube cancer, ovarian cancer, peritoneum cancer | Gynecologic Oncology Group | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT01223235 | Oct 2010 → Sep 2017 | fallopian tube cancer, ovarian cancer, peritoneum cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT01349647 Background | May 2011 → Jul 2015 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT06057948 Background | Sep 2023 → Mar 2027 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT00857545 Background | Jul 2010 → Sep 2015 | fallopian tube cancer, ovarian carcinoma, primary peritoneal carcinoma | Gynecologic Oncology Group | Completed | Missed primary |
| Phase 2 | NCT01141491 Comparator | Jun 2010 → Sep 2013 | sarcoma | MabVax Therapeutics, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 6
| 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. |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OBI-821 | “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 | Immunologic adjuvant OPT-821 | “Immunologic adjuvant OPT-821” NCT01141491 ↗ |
| Known as | OPT-821 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01141491 ↗ |
| Known as | QS-21 | “Comprised of the immunological adjuvant OPT-821 (QS-21)” NCT06057948 ↗ |
| Modality | Other / unclassified | “Saponin-based Immunoadjuvant” NCT00857545 ↗ |
| Route | Subcutaneous | “Given subcutaneously” NCT00693342 ↗ |