Budigalimab

also known as ABBV-181 · Budiglimab · PR-1648817

Developed for: cancer · HIV infectious disease · malignant pancreatic neoplasm · non-small cell lung carcinoma · colorectal cancer · hepatocellular carcinoma · triple-negative breast carcinoma · cancer of unknown primary site
+9 more
· gastroesophageal cancer · head and neck cancer · head and neck squamous cell carcinoma · metastatic neoplasm · ovarian cancer · ovarian serous adenocarcinoma · small cell lung carcinoma · squamous cell carcinoma · urothelial carcinoma
Investigated by: AbbVie · Trishula Therapeutics, Inc. · Idera Pharmaceuticals, Inc. · Stemcentrx

Trials 25 · a red edge is where a trial was stopped

today NCT07241039 · Ph 1 NCT06632951 · Ph 2 NCT06236438 · Ph 2/3 NCT06119217 · Ph 2 NCT06158958 · Ph 1 NCT06109272 · Ph 2/3 NCT06032546 · Ph 2 NCT05822752 · Ph 2 NCT05599984 · Ph 1 NCT05005403 · Ph 1 NCT04807972 · Ph 1 NCT04799353 · Ph 1 NCT04306900 · Ph 1 NCT04223804 · Ph 1 NCT03818542 · Ph 1 NCT04196283 · Ph 1 NCT03893955 · Ph 1 NCT03821935 · Ph 1 NCT03639194 · Ph 1 NCT03138408 · Ph 1 NCT03035279 · Ph 1 NCT02988960 · Ph 1 NCT03000257 · Ph 1 NCT02539719 · Ph 1 NCT01946074 · Ph 1

2014201520162017201820192020202120222023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 119 trials
Phase 1	NCT07241039	Nov 2025 → Apr 2029 expected	squamous cell carcinoma	AbbVie	Recruiting	No outcome recorded
Phase 1	NCT06158958	Feb 2024 → Oct 2025	cancer	AbbVie	Terminated	No outcome recorded
Phase 1	NCT05599984	Dec 2022 → Nov 2027 expected	cancer	AbbVie	Active not recruiting	No outcome recorded
Phase 1	NCT05005403	Nov 2021 → Jul 2027 expected	colorectal cancer, gastroesophageal cancer, head and neck squamous cell carcinoma, malignant pancreatic neoplasm +3	AbbVie	Recruiting	No outcome recorded
Phase 1	NCT04807972	May 2021 → Mar 2024	malignant pancreatic neoplasm	AbbVie	Terminated	No outcome recorded
Phase 1	NCT04799353	Mar 2021 → Oct 2022	HIV infectious disease	AbbVie	Completed	No outcome recorded
Phase 1	NCT04306900	Mar 2020 → Nov 2022	cancer	Trishula Therapeutics, Inc.	Completed	No outcome recorded
Phase 1	NCT04223804	Jan 2020 → Feb 2023	HIV infectious disease	AbbVie	Completed	No outcome recorded
Phase 1	NCT03818542	Jan → Sep 2020	head and neck cancer	AbbVie	Terminated	No outcome recorded
Phase 1	NCT04196283	Jan 2020 → Oct 2022	cancer of unknown primary site	AbbVie	Completed	No outcome recorded
Phase 1	NCT03893955	May 2019 → Mar 2026 overdue	metastatic neoplasm, non-small cell lung carcinoma, triple-negative breast carcinoma	AbbVie	Active not recruiting	No outcome recorded
Phase 1	NCT03821935	Feb 2019 → Jun 2027 expected	—	AbbVie	Active not recruiting	No outcome recorded
Phase 1	NCT03639194	Oct 2018 → Jan 2024	small cell lung carcinoma	AbbVie	Completed	No outcome recorded
Phase 1	NCT03138408	Jun 2017 → May 2019	cancer	AbbVie	Terminated	No outcome recorded
Phase 1	NCT03035279	Mar 2017 → Mar 2019	colorectal cancer	AbbVie	Terminated	No outcome recorded
Phase 1	NCT02988960	Feb 2017 → Sep 2026 expected	—	AbbVie	Active not recruiting	No outcome recorded
Phase 1	NCT03000257	Dec 2016 → Mar 2022	cancer	AbbVie	Completed	No outcome recorded
Phase 1	NCT02539719	Aug 2015 → Jan 2019	ovarian cancer	Stemcentrx	Terminated	No outcome recorded
Phase 1	NCT01946074	Aug 2013 → Sep 2022	cancer	AbbVie	Completed	No outcome recorded

Phase 24 trials
Phase 2	NCT06632951	Jan 2025 → Mar 2027 expected	urothelial carcinoma	AbbVie	Active not recruiting	No outcome recorded
Phase 2	NCT06119217	Mar 2024 → Nov 2025	malignant pancreatic neoplasm	Trishula Therapeutics, Inc.	Completed	No outcome recorded
Phase 2	NCT06032546	Oct 2023 → Sep 2025	HIV infectious disease	AbbVie	Terminated	No outcome recorded
Phase 2	NCT05822752	Sep 2023 → Nov 2026 expected	hepatocellular carcinoma	AbbVie	Active not recruiting	No outcome recorded
Phase 2/32 trials
Phase 2/3	NCT06236438	Apr 2024 → Oct 2031 expected	non-small cell lung carcinoma	AbbVie	Recruiting	No outcome recorded
Phase 2/3	NCT06109272	Jan 2024 → Sep 2030 expected	hepatocellular carcinoma	AbbVie	Recruiting	No outcome recorded

Also used as a comparator or background therapy in 4 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT06487559 Background	Sep 2024 → Oct 2027 expected	hepatocellular carcinoma	AbbVie	Recruiting	No outcome recorded
Phase 1	NCT03071757 Background	Mar 2017 → Apr 2022	—	AbbVie	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT06772623 Background	Mar 2025 → Nov 2027 expected	non-small cell lung carcinoma	AbbVie	Recruiting	No outcome recorded
Phase 21 trial
Phase 2	NCT06628310 Background	Dec 2024 → Oct 2030 expected	esophageal adenocarcinoma, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma	AbbVie	Recruiting	No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 32 sources stand behind the page.

Field	Value	Cited text
Known as	budigalimab	“budigalimab (formerly ABBV-181), an antibody targeting PD-1” PMID 32513564 ↗ Jun 2020 17 NCT05005403 ↗ NCT05599984 ↗ NCT06628310 ↗ NCT06487559 ↗ NCT06632951 ↗ NCT06032546 ↗ NCT03821935 ↗ NCT06772623 ↗ NCT05822752 ↗ NCT06109272 ↗ NCT06158958 ↗ NCT04799353 ↗ NCT07241039 ↗ NCT06236438 ↗ NCT03639194 ↗ NCT04306900 ↗ NCT06119217 ↗
Known as	ABBV-181	“A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination with Budigalimab (ABBV-181) in...” NCT07241039 ↗ 12 “budigalimab (ABBV-181)” NCT06158958 ↗ NCT02539719 ↗ NCT04196283 ↗ NCT03000257 ↗ NCT03138408 ↗ NCT03893955 ↗ NCT02988960 ↗ NCT04223804 ↗ NCT03035279 ↗ NCT03818542 ↗ NCT01946074 ↗ NCT03071757 ↗
Known as	Budiglimab	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04807972 ↗
Known as	PR-1648817	ChEMBL registry synonym — accepted as the source's own label CHEMBL4297858 ↗
Action	Inhibit	“It is in clinical development in combination with budigalimab, an anti-programmed cell death protein 1 Fc-modified mAb.” PMID 39534099 ↗ Oct 2024
Modality	Monoclonal antibody	“ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).” NCT02539719 ↗
Route	Intravenous	“ABBV-181 will be administered by intravenous infusion.” NCT01946074 ↗
Target	PDCD1	“ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).” NCT02539719 ↗