sotigalimab

also known as APX005M · APX-005 · EPI-0050

Developed for: melanoma · metastatic melanoma · non-small cell lung carcinoma · pancreatic adenocarcinoma · renal cell carcinoma · colorectal adenocarcinoma · cutaneous melanoma · diffuse intrinsic pontine glioma
+12 more
· ependymoma · esophageal cancer · gastroesophageal cancer · glioblastoma · head and neck cancer · medulloblastoma · ovarian cancer · pancreatic adenosquamous carcinoma · pancreatic ductal adenocarcinoma · rectum adenocarcinoma · soft tissue sarcoma · urothelial carcinoma
Investigated by: Apexigen America, Inc. · National Cancer Institute (NCI) · Bristol-Myers Squibb · M.D. Anderson Cancer Center · Pyxis Oncology, Inc · Yale University
+18 more
· A Kids' Brain Tumor Cure Foundation · Alexander Z. Wei, MD · American Lebanese Syrian Associated Charities · Arcus Biosciences, Inc. · Belgian Gynaecological Oncology Group · BioNTech US Inc. · Cancer Research Institute, New York City · GSO Global Clinical Research BV · James Cleary, MD, PhD · Lustgarten Foundation · Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Parker Institute for Cancer Immunotherapy · Pediatric Brain Tumor Consortium · Solving Kids' Cancer · Swiss GO Trial Group · The Central and Eastern European Gynecologic Oncology Group · Ty Louis Campbell Foundation · University of Texas Southwestern Medical Center

Trials 15

today NCT05201001 · Ph 2 NCT05419479 · Ph 1/2 NCT04495257 · Ph 1 NCT04130854 · Ph 2 NCT04337931 · Ph 2 NCT03719430 · Ph 2 NCT03597282 · Ph 1 NCT03502330 · Ph 1 NCT03389802 · Ph 1 NCT03165994 · Ph 2 NCT03214250 · Ph 1/2 NCT03123783 · Ph 1/2 NCT02706353 · Ph 1/2 NCT02600949 · Ph 1 NCT02482168 · Ph 1

201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 16 trials
Phase 1	NCT04495257	Sep 2020 → Mar 2026	melanoma, renal cell carcinoma	Yale University	Completed	No outcome recorded
Phase 1	NCT03597282	Oct 2018 → May 2020	metastatic melanoma	BioNTech US Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT03502330	Jun 2018 → Jan 2022	melanoma, non-small cell lung carcinoma, renal cell carcinoma	Yale University	Completed	No outcome recorded
Phase 1	NCT03389802	Mar 2018 → Sep 2023 overdue	diffuse intrinsic pontine glioma, ependymoma, glioblastoma, medulloblastoma	Pediatric Brain Tumor Consortium	Active not recruiting	No outcome recorded
Phase 1	NCT02600949	May 2016 → May 2027 expected	colorectal adenocarcinoma, pancreatic ductal adenocarcinoma	M.D. Anderson Cancer Center	Enrolling by invitation	No outcome recorded
Phase 1	NCT02482168	May 2015 → Jun 2018	head and neck cancer, melanoma, non-small cell lung carcinoma, urothelial carcinoma	Apexigen America, Inc.	Completed	No outcome recorded
Phase 1/24 trials
Phase 1/2	NCT05419479	Nov 2022 → May 2026	pancreatic adenocarcinoma, pancreatic adenosquamous carcinoma	James Cleary, MD, PhD	Suspended	No outcome recorded
Phase 1/2	NCT03214250	Jul 2017 → Feb 2021	pancreatic adenocarcinoma	Parker Institute for Cancer Immunotherapy	Completed	Mixed
Phase 1/2	NCT03123783	Jul 2017 → Nov 2020	metastatic melanoma, non-small cell lung carcinoma	Apexigen America, Inc.	Completed	No outcome recorded
Phase 1/2	NCT02706353	Jun 2017 → Mar 2025	melanoma	M.D. Anderson Cancer Center	Terminated	No outcome recorded Stop: Enrollment
Phase 25 trials
Phase 2	NCT05201001	Sep 2023	ovarian cancer	Nordic Society of Gynaecological Oncology - Clinical Trials Unit	Withdrawn	No outcome recorded
Phase 2	NCT04130854	Apr 2020 → Jan 2026	rectum adenocarcinoma	University of Texas Southwestern Medical Center	Completed	No outcome recorded
Phase 2	NCT04337931	Jun 2019 → Jul 2022	cutaneous melanoma, metastatic melanoma	Apexigen America, Inc.	Terminated	No outcome recorded Stop: Business
Phase 2	NCT03719430	Mar 2019 → Dec 2025	soft tissue sarcoma	Alexander Z. Wei, MD	Completed	No outcome recorded
Phase 2	NCT03165994	Oct 2017 → Nov 2022	esophageal cancer, gastroesophageal cancer	Apexigen America, Inc.	Completed	No outcome recorded

Press releases naming this drug 1 release

Date	Issuer	Release
2017-04-11	Bristol-Myers Squibb	Bristol-Myers Squibb and Apexigen, Inc. Announce Clinical Collaboration to Evaluate Opdivo (nivolumab) in Combination with APX005M in Advanced Solid Tumors bms.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

Field	Value	Cited text
Known as	sotigalimab	“We conducted a phase I trial of CD40 agonist APX005M (sotigalimab) and CSF1R inhibitor cabiralizumab with or without nivolumab using a 3+3 dose-escalation design (NCT03502330).” PMID 34140403 ↗ Jun 2021 3 “CD40 agonistic monoclonal antibody APX005M (sotigalimab)” PMID 33387490 ↗ Jan 2021 NCT04337931 ↗ NCT02600949 ↗
Known as	APX-005	ChEMBL registry synonym — accepted as the source's own label CHEMBL4297888 ↗
Known as	APX005M	“efficacy of sotigalimab (APX005M) administered at 2 different schedules” NCT04337931 ↗ 13 NCT03719430 ↗ NCT03123783 ↗ NCT02706353 ↗ NCT03389802 ↗ NCT04495257 ↗ NCT03214250 ↗ NCT04130854 ↗ NCT03165994 ↗ NCT05419479 ↗ NCT05201001 ↗ Show 3 more sources
Known as	EPI-0050	ChEMBL registry synonym — accepted as the source's own label CHEMBL4297888 ↗
Action	Activate	“CD40 agonistic monoclonal antibody” NCT02482168 ↗
Modality	Monoclonal antibody	“CD40 agonistic monoclonal antibody” NCT02482168 ↗
Route	Intravenous	“receive intravenous APX005M” NCT02482168 ↗
Target	CD40	“Intratumoral CD40 Agonistic Monoclonal Antibody APX005M” NCT02706353 ↗