Cabiralizumab

also known as FPA008 · BMS-986227

Monoclonal antibody targets CSF1R via inhibition

Developed for: cancer · malignant pancreatic neoplasm · non-small cell lung carcinoma · renal cell carcinoma · biliary tract cancer · cancer of unknown primary site · head and neck cancer · hepatocellular carcinoma
+9 more
· malignant glioma · melanoma · ovarian cancer · pancreatic exocrine neoplasm · pancreatic neoplasm · peripheral T-cell lymphoma, not otherwise specified · rheumatoid arthritis · tenosynovial giant cell tumor, diffuse type · triple-negative breast carcinoma
Investigated by: Bristol-Myers Squibb · Five Prime Therapeutics, Inc. · NYU Langone Health · Apexigen America, Inc. · Hitendra Patel · Lustgarten Foundation
+8 more
· National Cancer Institute (NCI) · Ono Pharmaceutical Co., Ltd. · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stand Up To Cancer · University of Chicago · University of Michigan Rogel Cancer Center · Washington University School of Medicine · Yale University

Trials 14 · a red edge is where a trial was stopped

today NCT04331067 · Ph 1/2 NCT03697564 · Ph 2 NCT04050462 · Ph 2 NCT03768531 · Ph 2 NCT03927105 · Ph 2 NCT03599362 · Ph 2 NCT03502330 · Ph 1 NCT03335540 · Ph 1 NCT03431948 · Ph 1 NCT03336216 · Ph 2 NCT03158272 · Ph 1 NCT02526017 · Ph 1 NCT02471716 · Ph 1/2 NCT01962337 · Ph 1

20142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 16 trials
Phase 1	NCT03502330	Jun 2018 → Jan 2022	melanoma, non-small cell lung carcinoma, renal cell carcinoma	Yale University	Completed	No outcome recorded
Phase 1	NCT03335540	May 2018 → Mar 2021	cancer of unknown primary site	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT03431948	Mar 2018 → Feb 2020	cancer	University of Chicago	Completed	No outcome recorded
Phase 1	NCT03158272	May 2017 → Oct 2019	cancer	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT02526017	Sep 2015 → Nov 2019	head and neck cancer, malignant glioma, malignant pancreatic neoplasm, non-small cell lung carcinoma +2	Five Prime Therapeutics, Inc.	Completed	No outcome recorded
Phase 1	NCT01962337	Oct 2013 → Apr 2016	rheumatoid arthritis	Five Prime Therapeutics, Inc.	Terminated	No outcome recorded
Phase 1/22 trials
Phase 1/2	NCT04331067	Nov 2020 → Mar 2023	triple-negative breast carcinoma	Washington University School of Medicine	Terminated	No outcome recorded
Phase 1/2	NCT02471716	Jun 2015 → Apr 2020	tenosynovial giant cell tumor, diffuse type	Five Prime Therapeutics, Inc.	Completed	No outcome recorded
Phase 26 trials
Phase 2	NCT03697564	Oct 2019 → Apr 2023	pancreatic exocrine neoplasm	Hitendra Patel	Completed	No outcome recorded
Phase 2	NCT04050462	Sep 2019 → Jan 2025	hepatocellular carcinoma	NYU Langone Health	Terminated	No outcome recorded
Phase 2	NCT03768531	Jun 2019 → Jan 2023	biliary tract cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Withdrawn	No outcome recorded
Phase 2	NCT03927105	Apr → Nov 2019	peripheral T-cell lymphoma, not otherwise specified	University of Michigan Rogel Cancer Center	Completed	No outcome recorded
Phase 2	NCT03599362	Jul 2018 → Jun 2020	malignant pancreatic neoplasm	NYU Langone Health	Terminated	No outcome recorded
Phase 2	NCT03336216	Dec 2017 → Jun 2023	pancreatic neoplasm	Bristol-Myers Squibb	Completed	No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

Field	Value	Cited text
Known as	Cabiralizumab	“Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks.” NCT03768531 ↗ 11 NCT03697564 ↗ NCT03502330 ↗ NCT03927105 ↗ NCT03599362 ↗ NCT03336216 ↗ NCT03335540 ↗ NCT03431948 ↗ NCT02526017 ↗ NCT04331067 ↗ NCT04050462 ↗ NCT03158272 ↗
Known as	BMS-986227	“A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies” NCT03158272 ↗ 1 “Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine” NCT03697564 ↗
Known as	FPA008	“A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies” NCT03158272 ↗ 2 NCT02471716 ↗ NCT01962337 ↗
Action	Inhibit	“an Anti-CSF1 Receptor Antibody” NCT02471716 ↗
Modality	Monoclonal antibody	“a CSF1-R monoclonal antibody” NCT02471716 ↗ 1 CHEMBL4297713 ↗
Route	Intravenous	“IV infusion” NCT02471716 ↗
Target	CSF1R	“CSF1R inhibitor cabiralizumab” PMID 34140403 ↗ Jun 2021