GI-6301

also known as GI-6301 Vaccine

Developed for: chordoma · colorectal cancer · malignant pancreatic neoplasm · non-small cell lung carcinoma · triple-negative breast carcinoma · adenocarcinoma · colonic neoplasm · cutaneous neuroendocrine carcinoma
+5 more
· head and neck squamous cell carcinoma · hepatocellular carcinoma · ovarian carcinoma · squamous cell carcinoma · urothelial carcinoma
Investigated by: ImmunityBio, Inc. · National Cancer Institute (NCI) · NantCell, Inc.

Trials 17

today NCT03563157 · Ph 1/2 NCT03554109 · Ph 2 NCT03647423 · Ph 1/2 NCT03169777 · Ph 1/2 NCT03563144 · Ph 2 NCT03586869 · Ph 1/2 NCT03574649 · Ph 2 NCT03563170 · Ph 1/2 NCT03169738 · Ph 1/2 NCT03387111 · Ph 1/2 NCT03197571 · Ph 1/2 NCT03197584 · Ph 1/2 NCT03175666 · Ph 1/2 NCT03169764 · Ph 1/2 NCT03167164 · Ph 1/2 NCT02383498 · Ph 2 NCT01519817 · Ph 1

2012201320142015201620172018201920202021202220232024202520262027

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 Stop: Enrollment
Phase 1/2	NCT03647423	Aug 2018 → Aug 2020	chordoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03169777	Aug 2018 → Jan 2019	colorectal cancer	ImmunityBio, Inc.	Withdrawn	No outcome recorded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Phase 1/2	NCT03563170	May 2018 → Aug 2019	hepatocellular carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1/2	NCT03169738	Feb 2018 → Jan 2019	non-small cell lung carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded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Phase 1/2	NCT03197571	Dec 2017 → Jan 2019	urothelial carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03197584	Dec 2017 → Feb 2019	ovarian carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03175666	Dec 2017 → Jan 2019	triple-negative breast carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03169764	Dec 2017 → Jan 2019	head and neck squamous cell carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded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	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
Comparator or background therapy2 trials
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

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
2014-10-17	GlobeImmune	Results Updated Chordoma Data From Phase 1 Study of GI-6301 Presented at 2014 Connective Tissue Oncology Society (CTOS) Annual Meeting globeimmune.com ↗ GlobeImmune, Inc., today announced that updated results from eleven chordoma patients in the GI-6301 Phase 1 trial were presented at the 2014 CTOS Annual Meeting in Berlin, Germany.

All press releases naming this drug 1 release

Date	Issuer	Release
2014-10-17	GlobeImmune	Updated Chordoma Data From Phase 1 Study of GI-6301 Presented at 2014 Connective Tissue Oncology Society (CTOS) Annual Meeting globeimmune.com ↗

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 ↗ 18 NCT03169764 ↗ NCT01519817 ↗ NCT03175666 ↗ NCT03167177 ↗ NCT03563170 ↗ NCT03563157 ↗ NCT03387111 ↗ NCT03574649 ↗ NCT03169738 ↗ NCT03169777 ↗ Show 8 more sources
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 ↗