Phase 1 Study of the Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Start Date01 Mar 2011

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with IMC-3C5

100 Translational Medicine associated with IMC-3C5

100 Patents (Medical) associated with IMC-3C5

Literatures (Medical) associated with IMC-3C5

01 Oct 2016·Cancer Chemotherapy and PharmacologyQ4 · MEDICINE

Phase 1 study of the anti-vascular endothelial growth factor receptor 3 monoclonal antibody LY3022856/IMC-3C5 in patients with advanced and refractory solid tumors and advanced colorectal cancer

Q4 · MEDICINE

Article

Author: Pytowski, Bronislaw ; Knost, James A ; Saif, Muhammad Wasif ; Qin, Amy ; Kauh, John S ; Chiorean, E Gabriela ; O'Neil, Bert H ; Yu, Danni ; Kambhampati, Siva Rama Prasad

PURPOSEMetastasis of solid tumors to regional lymph nodes is facilitated by tumor lymphangiogenesis, which is primarily mediated by the vascular endothelial growth factor receptor 3 (VEGFR-3). We conducted a phase 1 dose-escalation (part A) study of the VEGFR-3 human immunoglobulin G subclass 1 monoclonal antibody LY3022856 in advanced solid tumors, followed by a colorectal cancer (CRC) expansion (part B).METHODSPart A evaluated the safety profile and maximum tolerated dose (MTD) of LY3022856 in patients treated intravenously at doses of 5-30 mg/kg weekly (qwk). Part B further evaluated tolerability in CRC patients treated with 30 mg/kg. Secondary objectives were pharmacokinetics, anti-tumor activity, and pharmacodynamics (exploratory).RESULTSA total of 44 patients (23 in part A; 21 in part B) were treated; only one dose-limiting toxicity was observed at the lowest dose level. The MTD was not reached. Treatment-emergent adverse events (TEAEs) of any grade included in ≥15 % of all patients were: nausea (41 %), fatigue (32 %), vomiting (30 %), decreased appetite (27 %), pyrexia (25 %), peripheral edema (23 %), and urinary tract infection (UTI, 20 %). The most common grade 3/4 TEAEs included UTI and small intestinal obstruction (7 % each). No radiographic responses were noted. Median progression-free survival in part B was 6.3 weeks (95 % confidence interval: 5.1, 14.4), and a best overall response of stable disease was observed in 4 CRC patients (19.0 %).CONCLUSIONSLY3022856 was well tolerated up to a dose of 30 mg/kg qwk, but with minimal anti-tumor activity in CRC. CLINICALTRIALS.GOV IDENTIFIERNCT01288989.

100 Deals associated with IMC-3C5

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 1	US	Eli Lilly & Co.	26 Sep 2016
Neoplasms	Phase 1	-	Ludwig Institute for Cancer Research Ltd.	-
Advanced Malignant Solid Neoplasm	Preclinical	US	Eli Lilly & Co.	01 Mar 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01288989 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	44	IMC-3C5 (5 mg/kg IMC-3C5)	vhngwdzwnz(nbsctcbxdq) = saeoyyopwt bxyzflxxpv (scaqatbonn, klqqtljgqe - jtjibwgmkk) View more	-	17 Jun 2019
				IMC-3C5 (10 mg/kg IMC-3C5)	vhngwdzwnz(nbsctcbxdq) = waajitkztn bxyzflxxpv (scaqatbonn, pshxnthhfc - ejnmzzodtr) View more
NCT01288989 (Pubmed \| Cancer Chemother Pharmacol) Manual	Phase 1	Solid tumor \| Colorectal Cancer	44	LY3022856 (solid tumors)	(abyiopuzjj) = Treatment-emergent adverse events (TEAEs) of any grade included in ≥15 % of all patients were: nausea (41 %), fatigue (32 %), vomiting (30 %), decreased appetite (27 %), pyrexia (25 %), peripheral edema (23 %), and urinary tract infection (UTI, 20 %). scpmqxzhjz (qwdzdqnrot ) View more	Negative	01 Oct 2016
				LY3022856 (CRC)

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