GI-4000

Developed for: malignant pancreatic neoplasm · non-small cell lung carcinoma · colorectal cancer · triple-negative breast carcinoma · colon carcinoma · head and neck squamous cell carcinoma · hepatocellular carcinoma · ovarian carcinoma
+2 more
· squamous cell carcinoma · urothelial carcinoma
Investigated by: ImmunityBio, Inc. · GlobeImmune · Georgetown University · Memorial Sloan Kettering Cancer Center · University of Pennsylvania

Trials 19 · a red edge is where a trial was stopped

today NCT03563157 · Ph 1/2 NCT03554109 · Ph 2 NCT03563144 · Ph 2 NCT03169777 · Ph 1/2 NCT03586869 · Ph 1/2 NCT03574649 · Ph 2 NCT03563170 · Ph 1/2 NCT03169738 · Ph 1/2 NCT03387111 · Ph 1/2 NCT03387098 · Ph 1/2 NCT03175666 · Ph 1/2 NCT03197571 · Ph 1/2 NCT03169764 · Ph 1/2 NCT03197584 · Ph 1/2 NCT03329248 · Ph 1/2 NCT03136406 · Ph 1/2 NCT01322815 · Ph 2 NCT00655161 · Ph 2 NCT00837135 · Ph 1

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT00837135	Jan 2008 → Oct 2009	malignant pancreatic neoplasm	University of Pennsylvania	Withdrawn	No outcome recorded
Phase 1/213 trials
Phase 1/2	NCT03563157	Sep 2018 → Apr 2019	colorectal cancer	ImmunityBio, Inc.	Terminated	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Phase 1/2	NCT03169777	Aug 2018 → Jan 2019	colorectal cancer	ImmunityBio, Inc.	Withdrawn	No outcome recorded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Phase 1/2	NCT03563170	May 2018 → Aug 2019	hepatocellular carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03169738	Feb 2018 → Jan 2019	non-small cell lung carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded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	NCT03387098	Dec 2017 → Sep 2018	malignant pancreatic neoplasm	ImmunityBio, Inc.	Terminated	No outcome recorded
Phase 1/2	NCT03175666	Dec 2017 → Jan 2019	triple-negative breast carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03197571	Dec 2017 → Jan 2019	urothelial carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03169764	Dec 2017 → Jan 2019	head and neck squamous cell carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded
Phase 1/2	NCT03197584	Dec 2017 → Feb 2019	ovarian carcinoma	ImmunityBio, Inc.	Withdrawn	No outcome recorded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	NCT03329248	Nov 2017 → Aug 2018	malignant pancreatic neoplasm	ImmunityBio, Inc.	Terminated	No outcome recorded
Phase 1/2	NCT03136406	Aug → Nov 2017	malignant pancreatic neoplasm	ImmunityBio, Inc.	Terminated	No outcome recorded

Phase 25 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	NCT01322815	Oct 2010 → Sep 2014	colon carcinoma	Georgetown University	Terminated	No outcome recorded
Phase 2	NCT00655161	Apr 2008 → Nov 2013	non-small cell lung carcinoma	GlobeImmune	Completed	No outcome recorded

Also used as a comparator or background therapy in 2 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/21 trial
Phase 1/2	NCT03387085 Background	Mar 2018 → Sep 2020	triple-negative breast carcinoma	ImmunityBio, Inc.	Terminated	No outcome recorded
Phase 21 trial
Phase 2	NCT00300950 Comparator	Jan 2006 → Feb 2015	malignant pancreatic neoplasm	GlobeImmune	Completed	No outcome recorded

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

Field	Value	Cited text
Known as	GI-4000	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03574649 ↗ 20 NCT03136406 ↗ NCT03387098 ↗ NCT00837135 ↗ NCT03197571 ↗ NCT03563144 ↗ NCT03387111 ↗ NCT03554109 ↗ NCT01322815 ↗ NCT00655161 ↗ NCT03563170 ↗ NCT03387085 ↗ NCT03175666 ↗ NCT03329248 ↗ NCT03169777 ↗ NCT00300950 ↗ NCT03197584 ↗ NCT03169764 ↗ NCT03169738 ↗ NCT03563157 ↗ NCT03586869 ↗
Modality	Vaccine	“The GI-4000 therapeutic vaccine or placebo will be injected under the skin” NCT00300950 ↗
Route	Subcutaneous	“The GI-4000 therapeutic vaccine or placebo will be injected under the skin” NCT00300950 ↗