Varlilumab

also known as CDX-1127 · 1F5

Monoclonal antibody targets CD27 via activation

Developed for: clear cell renal carcinoma · melanoma · Burkitt lymphoma · glioblastoma · non-small cell lung carcinoma · ovarian carcinoma · ALK-positive large B-cell lymphoma · astrocytic tumor
+39 more
· B-cell chronic lymphocytic leukemia · breast carcinoma · colorectal adenocarcinoma · colorectal cancer · diffuse large B-cell lymphoma activated B-cell type · diffuse large B-cell lymphoma germinal center B-cell type · diffuse large B-cell lymphoma of the central nervous system · diffuse large B-cell lymphoma with chronic inflammation · distal biliary tract carcinoma · gallbladder carcinoma · head and neck cancer · head and neck squamous cell carcinoma · high grade B-cell lymphoma · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · Hodgkins lymphoma · hormone-resistant prostate carcinoma · intrahepatic cholangiocarcinoma · intravascular large B-cell lymphoma · large B-cell lymphoma · lymphomatoid granulomatosis · mantle cell lymphoma · marginal zone lymphoma · mediastinal gray zone lymphoma · metastatic melanoma · mucocutaneous ulceration, chronic · oligoastrocytoma · oligodendroglioma · plasmablastic lymphoma · primary central nervous system lymphoma · primary cutaneous diffuse large B-cell lymphoma, Leg type · primary effusion lymphoma · primary mediastinal large B-cell lymphoma · prostate cancer · renal cell carcinoma · T-cell and NK-cell neoplasm · T-cell/histiocyte rich large B cell lymphoma · triple-negative breast carcinoma · urinary bladder cancer · B-cell non-Hodgkin lymphoma
Investigated by: Celldex Therapeutics · National Cancer Institute (NCI) · Annick Desjardins, MD · Bristol-Myers Squibb · Cascadian Therapeutics Inc. · Craig L Slingluff, Jr
+4 more
· Genentech, Inc. · James Larner, MD · Nicholas Butowski · Rutgers, The State University of New Jersey

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

today NCT04941287 · Ph 2 NCT03688178 · Ph 2 NCT04081688 · Ph 1 NCT03038672 · Ph 2 NCT03617328 · Ph 1/2 NCT02924038 · Ph 1 NCT02543645 · Ph 1 NCT02386111 · Ph 1 NCT02413827 · Ph 1/2 NCT02335918 · Ph 1/2 NCT02302339 · Ph 2 NCT02270372 · Ph 1 NCT02284971 · Ph 1 NCT01460134 · Ph 1

2012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 17 trials
Phase 1	NCT04081688	Sep 2019 → Apr 2022	non-small cell lung carcinoma	Rutgers, The State University of New Jersey	Terminated	No outcome recorded
Phase 1	NCT02924038	Apr 2017 → Dec 2022	astrocytic tumor, oligoastrocytoma, oligodendroglioma	Nicholas Butowski	Terminated	No outcome recorded
Phase 1	NCT02543645	Oct 2015 → Apr 2017	clear cell renal carcinoma, head and neck cancer, melanoma, non-small cell lung carcinoma +2	Celldex Therapeutics	Terminated	No outcome recorded
Phase 1	NCT02386111	May 2015 → Aug 2017	clear cell renal carcinoma	Celldex Therapeutics	Terminated	No outcome recorded
Phase 1	NCT02270372	Nov 2014 → Jun 2016	breast carcinoma, ovarian carcinoma	Cascadian Therapeutics Inc.	Completed	No outcome recorded
Phase 1	NCT02284971	Nov 2014 → Apr 2016	prostate cancer	James Larner, MD	Terminated	No outcome recorded
Phase 1	NCT01460134	Oct 2011 → Dec 2015	B-cell chronic lymphocytic leukemia, Burkitt lymphoma, Hodgkins lymphoma, T-cell and NK-cell neoplasm +6	Celldex Therapeutics	Completed	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT03617328	Nov 2018 → Jan 2024	melanoma	Craig L Slingluff, Jr	Completed	No outcome recorded
Phase 1/2	NCT02413827	Apr 2015 → Nov 2016	metastatic melanoma	Celldex Therapeutics	Terminated	No outcome recorded
Phase 1/2	NCT02335918	Jan 2015 → Dec 2018	colorectal cancer, glioblastoma, head and neck squamous cell carcinoma, ovarian carcinoma +1	Celldex Therapeutics	Completed	No outcome recorded
Phase 24 trials
Phase 2	NCT04941287	Dec 2021 → Jan 2024 overdue	distal biliary tract carcinoma, gallbladder carcinoma, intrahepatic cholangiocarcinoma	National Cancer Institute (NCI)	Active not recruiting	No outcome recorded
Phase 2	NCT03688178	Aug 2020 → Mar 2027 expected	glioblastoma	Annick Desjardins, MD	Active not recruiting	No outcome recorded
Phase 2	NCT03038672	Dec 2018 → May 2023 overdue	ALK-positive large B-cell lymphoma, Burkitt lymphoma, T-cell/histiocyte rich large B cell lymphoma, diffuse large B-cell lymphoma activated B-cell type +14	National Cancer Institute (NCI)	Active not recruiting	No outcome recorded
Phase 2	NCT02302339	Nov 2014 → Jun 2018	melanoma	Celldex Therapeutics	Terminated	No outcome recorded

Also used as a comparator or background therapy in 1 trial

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/2	NCT03307746 Comparator	Nov 2017 → Feb 2021	B-cell non-Hodgkin lymphoma	University Hospital Southampton NHS Foundation Trust	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	Varlilumab	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02270372 ↗ 11 NCT03688178 ↗ NCT02543645 ↗ NCT03307746 ↗ NCT02302339 ↗ NCT02386111 ↗ NCT02335918 ↗ NCT02413827 ↗ NCT02924038 ↗ NCT03038672 ↗ NCT04081688 ↗ NCT04941287 ↗
Known as	1F5	“Varlilumab (1F5, CDX-1127) is a recombinant and fully human IgG1kappa mAb that binds to human CD27 with high affinity (62).” NCT03307746 ↗
Known as	CDX-1127	“A Phase l/ll, Open Label, Dose-escalation Study of Varlilumab (CDX-1127) in Combination With Atezolizumab (MPDL3280A, Anti-PD-L1) in Patients With Advanced Cancer” NCT02543645 ↗ 5 “Varlilumab (1F5, CDX-1127) is a recombinant and fully human IgG1kappa mAb that binds to human CD27 with high affinity (62).” NCT03307746 ↗ “Varlilumab (CDX-1127)” NCT02413827 ↗ NCT02284971 ↗ NCT03617328 ↗ NCT01460134 ↗
Action	Activate	“varlilumab, a fully human agonist anti-CD27 mAb” PMID 35940825 ↗ Aug 2022
Modality	Monoclonal antibody	“mAb” NCT02270372 ↗
Route	Intravenous	“varlilumab administered IV once every 3 weeks x 3 doses” NCT02270372 ↗
Target	CD27	“specifically binds human CD27” NCT02270372 ↗