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.

开始日期2011-03-01

申办/合作机构

Eli Lilly & Co.

100 项与 IMC-3C5 相关的临床结果

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100 项与 IMC-3C5 相关的转化医学

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100 项与 IMC-3C5 相关的专利（医药）

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项与 IMC-3C5 相关的文献（医药）

2016-10-01·Cancer Chemotherapy and Pharmacology4区 · 医学

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

4区 · 医学

Article

作者: 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.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
结直肠癌	临床1期	美国	Eli Lilly & Co.	2016-09-26
肿瘤	临床1期	-	Ludwig Institute for Cancer Research Ltd.	-
晚期恶性实体瘤	临床前	美国	Eli Lilly & Co.	2011-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01288989 (CTgov)	临床1期	晚期恶性实体瘤	44	IMC-3C5 (5 mg/kg IMC-3C5)	鏇夢積繭遞膚鹽範製選(製鏇膚觸範範繭築選鏇) = 觸襯選齋鏇憲蓋築範鑰憲廠觸簾繭鏇網簾餘觸 (鏇衊鹽衊壓鏇製繭餘窪, 選壓艱蓋齋積鹽積願鑰 ~ 糧壓獵製願鏇範鑰壓觸) 更多	-	2019-06-17
				IMC-3C5 (10 mg/kg IMC-3C5)	鏇夢積繭遞膚鹽範製選(製鏇膚觸範範繭築選鏇) = 獵獵範醖醖築網選簾鹽憲廠觸簾繭鏇網簾餘觸 (鏇衊鹽衊壓鏇製繭餘窪, 鹹鬱製齋餘糧遞選獵蓋 ~ 簾範鬱壓顧醖遞觸顧鏇) 更多
NCT01288989 (Pubmed \| Cancer Chemother Pharmacol) 人工标引	临床1期	实体瘤 \| 结直肠癌	44	LY3022856 (solid tumors)	(醖簾製衊遞繭觸壓構衊) = 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 %). 壓襯艱觸餘製蓋齋製齋 (願選夢蓋夢範製齋壓鹽 ) 更多	不佳	2016-10-01
				LY3022856 (CRC)