Delving into the Latest Updates on Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research) with Synapse

The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to be safe in previous studies and has also been indicated as potential intervention in breast cancer. The study of this new agent in advanced breast cancer may contribute to the development of new strategies for patients that progressed after hormonal treatment.

Start Date01 Nov 2013

Sponsor / Collaborator

Instituto do Cancer do Estado de Sao Paulo

[+2]

NCT01137071 / TerminatedPhase 2

A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

Start Date01 Apr 2011

Sponsor / Collaborator

Recepta Biopharma SA

NCT00617773 / CompletedPhase 2

A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Start Date01 May 2008

Sponsor / Collaborator

Recepta Biopharma SA

100 Clinical Results associated with Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research)

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100 Translational Medicine associated with Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research)

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100 Patents (Medical) associated with Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research)

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37

Literatures (Medical) associated with Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research)

01 Apr 2022·PHARMACOLOGY & THERAPEUTICS

Partners in crime: The Lewis Y antigen and fucosyltransferase IV in Helicobacter pylori-induced gastric cancer

Review

Author: Shukla, Shruti ; Yoshitomi, Hisae ; Bajpai, Vivek K ; Huh, Yun Suk ; Chakraborty, Abhijit ; Bajpai, Vivek K. ; Sonwal, Sonam ; Hwang, Seung-Kyu ; Xiao, Jianbo ; Khan, Imran ; Lee, Hoomin ; Haldorai, Yuvaraj ; Aziz, Faisal ; Han, Young-Kyu ; Yan, Qiu ; Dey, Debasish Kumar

Helicobacter pylori (H. pylori) is a major causative agent of chronic gastritis, gastric ulcer and gastric carcinoma. H. pylori cytotoxin associated antigen A (CagA) plays a crucial role in the development of gastric cancer. Gastric cancer is associated with glycosylation alterations in glycoproteins and glycolipids on the cell surface. H. pylori cytotoxin associated antigen A (CagA) plays a significant role in the progression of gastric cancer through post-translation modification of fucosylation to develop gastric cancer. The involvement of a variety of sugar antigens in the progression and development of gastric cancer has been investigated, including type II blood group antigens. Lewis Y (LeY) is overexpressed on the tumor cell surface either as a glycoprotein or glycolipid. LeY is a difucosylated oligosaccharide, which is catalyzed by fucosyltransferases such as FUT4 (α1,3). FUT4/LeY overexpression may serve as potential correlative biomarkers for the prognosis of gastric cancer. We discuss the various aspects of H. pylori in relation to fucosyltransferases (FUT1-FUT9) and its fucosylated Lewis antigens (LeY, LeX, LeA, and LeB) and gastric cancer. In this review, we summarize the carcinogenic effect of H. pylori CagA in association with Le^Y and its synthesis enzyme FUT4 in the development of gastric cancer as well as discuss its importance in the prognosis and its inhibition by combination therapy of anti-Le^Y antibody and celecoxib through MAPK signaling pathway preventing gastric carcinogenesis.

01 Apr 2021·International journal of gynecological cancer : official journal of the International Gynecological Cancer SocietyQ3 · MEDICINE

Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission

Q3 · MEDICINE

Article

Author: Hoffman, Eric W ; de Morais, Ana Luiza Gomes ; Cunha-Junior, Geraldo Felício ; Azevedo, Sergio J ; Smaletz, Oren ; Nascimento, Ivana L O ; Moro, Ana Maria ; Dos Santos, Mariana Lopes ; Majumder, Indrani ; Alves, Venancio A ; Ismael, Gustavo ; Yeda, Fernanda P ; Del Pilar Estevez-Diz, Maria

Objective:

To investigate the efficacy and safety of hu3S193, a humanized anti-Lewis-Y monoclonal antibody, as a consolidation strategy in patients with platinum-sensitive recurrent epithelial ovarian cancer who achieved a second complete response after salvage platinum-doublet chemotherapy.

Methods:

This single-arm phase II study accrued patients with recurrent epithelial ovarian cancer with Lewis-Y expression by immunohistochemistry who had achieved a second complete response after five to eight cycles of platinum-based chemotherapy. Patients received intravenous infusions of hu3S193, 30 mg/m2every 2 weeks starting no more than 8 weeks after the last dose of chemotherapy and continuing for 12 doses, until disease progression, or unacceptable toxicity. The primary endpoint was progression-free survival of the second remission. Secondary objectives were safety and pharmacokinetics.

Results:

Twenty-nine patients were enrolled. Most had a papillary/serous histology tumor (94%), stage III disease at diagnosis (75%), and five (17%) underwent secondary cytoreduction before salvage chemotherapy. Two patients were not eligible for efficacy but were considered for toxicity analysis. Eighteen patients (62%) completed the full consolidation treatment while nine patients progressed on treatment. At the time of analysis, 23 patients (85%) of the eligible population had progressed and seven of these patients (26%) had died. Median progression-free survival of the second remission was 12.1 months (95% CI: 10.6–13.9), with a 1-year progression-free survival of the second remission rate of 50.1%. The trial was terminated early since it was unlikely that the primary objective would be achieved. The most commonly reported treatment-related adverse events were nausea (55%) and vomiting (51%).

Conclusions:

Hu3S193 did not show sufficient clinical activity as consolidation therapy in patients with recurrent epithelial ovarian cancer who achieved a second complete response after platinum-based chemotherapy.

Trial registration:

NCT01137071.

01 Jan 2021·Clinics (Sao Paulo, Brazil)Q4 · MEDICINE

Phase II trial of humanized anti-Lewis Y monoclonal antibody for advanced hormone receptor-positive breast cancer that progressed following endocrine therapy

Q4 · MEDICINE

ArticleOA

Author: Mano, Max ; Serrano, Sergio V ; Crocamo, Susanne ; Freitas-Junior, Ruffo ; Hoff, Paulo M ; Smaletz, Oren ; Arai, Roberto Jun ; Bonadio, Renata Colombo ; Testa, Laura ; Zorzetto, Marina M Costa

OBJECTIVES:

The Lewis-Y antigen is expressed in 44%-90% of breast cancers (BCs). The expression of the antigen in carcinoma tissue differs from that in normal tissues. This study aimed to evaluate the clinical benefit of the humanized anti-Lewis Y monoclonal antibody, hu3S193, in advanced hormone receptor-positive and Lewis Y-positive BC after administration of endocrine therapy (ET).

METHODS:

A single-arm phase II study was conducted in seven centers. Patients with advanced hormone receptor-positive BC who failed first-line ET were included. The inclusion criterion was the observation of tumoral expression of the Lewis Y antigen during immunohistochemistry. The treatment comprised hu3S193 antibody administration at weekly intravenous doses of 20 mg/m2 for 8-week cycles. The primary endpoint was the clinical benefit rate. ClinicalTrials.gov NCT01370239.

RESULTS:

The study stopped accrual following an unplanned interim analysis as the hu3S193 antibody lacked sufficient activity to justify continuation of the study. Twenty-two patients were enrolled, of whom 21 were included in the efficacy analysis. The clinical benefit rate was 19%, with four patients presenting with stable disease after 24 weeks. One patient with prolonged stable disease received medication for over 2 years. No partial or complete responses were observed. The median time to progression and overall survival was 5.4 and 37.5 months, respectively.

CONCLUSIONS:

The humanized anti-Lewis Y monoclonal antibody, hu3S193, exhibited insufficient activity in this cohort. However, the possibility of activity in a more strictly selected subgroup of patients with higher levels of Lewis Y tumoral expression cannot be overlooked.

100 Deals associated with Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Ovarian Carcinoma	Phase 2	BR	Recepta Biopharma SA	30 Jan 2022
Advanced breast cancer	Phase 2	BR	Recepta Biopharma SA	01 Nov 2013
Platinum-Sensitive Ovarian Carcinoma	Phase 2	BR	Recepta Biopharma SA	01 Apr 2011
Recurrent Primary Peritoneal Serous Adenocarcinoma	Phase 2	BR	Recepta Biopharma SA	01 Apr 2011
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	BR	Recepta Biopharma SA	01 May 2008
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	BR	Recepta Biopharma SA	01 May 2008
Breast Cancer	Phase 2	-	University of Sao Paulo	-
Breast Cancer	Phase 2	-	Ludwig Institute for Cancer Research Ltd.	-
Fallopian Tube Carcinoma	Phase 2	-	University of Sao Paulo	-
Fallopian Tube Carcinoma	Phase 2	-	Ludwig Institute for Cancer Research Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00084799 (CTgov)	Phase 1	Small Cell Lung Cancer	10	monoclonal antibody hu3S193 (hu3S193 10 mg/m2)	oekuozdwkb(iqudottleh) = iwqoiluirj dcpnkqxodt (larvagpkts, tewkyrhfxa - rmcjfxzfch) View more	-	08 Feb 2022
				monoclonal antibody hu3S193 (hu3S193 20 mg/m2)	oekuozdwkb(iqudottleh) = mivagqhylo dcpnkqxodt (larvagpkts, kqajkruqxk - uofokdteez) View more
NCT00072410 (CTgov)	Phase 1	Ovarian Epithelial Carcinoma	7	111In-hu3S193 (Cohort 1)	frckstbbnv(rbjvujnvac) = gewyftoedl czeonjtflu (puxvcwlfir, rqlildcmlb - uhmzkumpfo) View more	-	21 Dec 2021
				111In-hu3S193 (Cohort 2)	frckstbbnv(rbjvujnvac) = tufbkqsgio czeonjtflu (puxvcwlfir, locwcvncep - vzbasdzgnb) View more
NCT01370239 (Pubmed \| Clinics (Sao Paulo)) Manual	Phase 2	Hormone receptor positive breast cancer Second line hormone receptor-positive	21	hu3s193	gbufwwozwh(ahtquvhaob) = mxyfrevrhd clzqkubjjs (pzqkohzsta ) View more	Positive	11 Oct 2021
NCT00006099 (CTgov)	Phase 1	Ovarian Cancer	1	Monoclonal antibody hu3S193 (Intraperitoneal (IP) Infusion of 111In-hu3S193)	jhaduxzlfz(wvgrttefzb) = hsolcfxynq djmwcmcywf (sulkdhkvex, spwstbnkto - cjooxdgcje) View more	-	12 Aug 2021
				Monoclonal antibody hu3S193 (Intravenous Infusion of 111In-hu3S193)	qjxxzbjukw(aduchleiua) = ojqvynhliu lromeatcdj (otxddodhxw, lxdfibqtep - tzbolinxck) View more
NCT00006046 (CTgov)	Phase 1	Advanced Colorectal Adenocarcinoma	7	monoclonal antibody hu3S193 (Hu3S193 10 mg/m2)	dpyuxglexa(souymzoftt) = bwxctuvgwl mzaoeeiswo (isayslklet, qvejohshcx - cezklvedsi) View more	-	09 Aug 2021
				monoclonal antibody hu3S193 (Hu3S193 25 mg/m2)	dpyuxglexa(souymzoftt) = mngvekymgf mzaoeeiswo (isayslklet, qnmqeudswa - qclfvbmhjm) View more
NCT01137071 (ASCO2017)	Phase 2	Platinum-Sensitive Ovarian Carcinoma Consolidation	29	hu3S193	cjrguzhkad(qdndcbhvcz) = lglgrnypam nipewqizfr (wwwcbjpogf, 10.6 - 13.9)	Negative	30 May 2017
NCT00617773 (CTgov)	Phase 2	Primary peritoneal carcinoma \| Platinum-Resistant Fallopian Tube Carcinoma \| Platinum-Resistant Primary Peritoneal Carcinoma	31	hu3S193	wcwlovhpfx(mwcfppvfyu) = ynedlctikf tvdlzjzemp (crycvjvixi, etmalzptya - lirtuznhfm) View more	-	26 Nov 2013
ASCO2011	Phase 2	Primary peritoneal carcinoma \| Fallopian Tube Carcinoma	31	hu3S193	iocawjpctt(aveiofimrm) = nzupuslpvq rkpisslrhf (ngqflajzmw, 4 - 15)	-	20 May 2011
ASCO2006	Phase 1	Small Cell Lung Cancer	10	hu3S193 10mg/m2	gwxtghnvmz(hxealwdkvu) = mfzahxjsjx yzswxfqtqw (xjfucqxenq, 0.84)	-	20 Jun 2006
				hu3S193 20mg/m2	gwxtghnvmz(hxealwdkvu) = ptargpmawl yzswxfqtqw (xjfucqxenq, 0.66)
ASCO2004	Phase 1	Advanced cancer	12	hu3S193	smvqcxjscv(pwdgdpmojk) = nhtxqomqyg bnbubheume (powkgzdugd ) View more	-	15 Jul 2004