Drugs / GI-6301
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01519817 | Jan 2012 → Mar 2016 | adenocarcinoma, colonic neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/212 trials | ||||||
| Phase 1/2 | NCT03563157 | Sep 2018 → Apr 2019 | colorectal cancer | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03647423 | Aug 2018 → Aug 2020 | chordoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169777 | Aug 2018 → Jan 2019 | colorectal cancer | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03586869 | Jul 2018 → Apr 2019 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03563170 | May 2018 → Aug 2019 | hepatocellular carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169738 | Feb 2018 → Jan 2019 | non-small cell lung carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03387111 | Jan 2018 → Apr 2019 | squamous cell carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03169764 | Dec 2017 → Jan 2019 | head and neck squamous cell carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03197571 | Dec 2017 → Jan 2019 | urothelial carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03175666 | Dec 2017 → Jan 2019 | triple-negative breast carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03197584 | Dec 2017 → Feb 2019 | ovarian carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03167164 | Dec 2017 → Jan 2019 | cutaneous neuroendocrine carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03554109 | Sep 2018 → Jun 2020 | triple-negative breast carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03563144 | Aug 2018 → Dec 2019 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03574649 | Jun → Aug 2018 | non-small cell lung carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT02383498 | May 2015 → Sep 2019 | chordoma | NantCell, Inc. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03387085 Background | Mar 2018 → Sep 2020 | triple-negative breast carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03167177 Background | Dec 2017 → Jan 2019 | melanoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GI-6301 | “A combination of agents will be administered to subjects in this study: Aldoxorubicin Hydrochloride HCI, ALT-803, ETBX-051, ETBX-061, GI-6301, haNK, avelumab, cetuximab,...” NCT03647423 ↗ |
| Known as | GI-6301 Vaccine | “GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury.” NCT02383498 ↗ |
| Modality | Vaccine | “GI-6301 (Yeast-Brachyury vaccine) has been tested in vitro and in the mouse model.” NCT01519817 ↗ |
| Route | Subcutaneous | “GI-6301 (Yeast-Brachyury vaccine) will be administered subcutaneously at 4 sites biweekly for 7 visits” NCT01519817 ↗ |