Delving into the Latest Updates on 90Y-DOTA-M5A with Synapse

Overview

Basic Info

Drug Type

Radiolabeled antibody, Diagnostic radiopharmaceuticals

Synonyms

Yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, 90Y-DOTA-M5A

Target

CEA

Action

inhibitors

Mechanism

CEA inhibitors(Carcinoembryonic antigen inhibitors)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication-

Inactive Indication

Advanced Malignant Solid NeoplasmLiver metastasesMetastatic Colorectal Carcinoma+ [2]

Originator Organization

City of Hope National Medical Center

Active Organization-

Inactive Organization

City of Hope National Medical Center

License Organization-

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or carry tumor-killing substances to them without harming normal cells. Giving radioactive substances together with antibodies may be effective treatment for some advanced cancers. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving radiolabeled monoclonal antibodies together with combination chemotherapy and bevacizumab may be an effective treatment for colorectal cancer.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of yttrium Y 90 DOTA anti-CEA (Carcinoembryonic antigen) monoclonal antibody M5A when given together with combination chemotherapy and bevacizumab in treating patients with metastatic colorectal cancer.

Start Date01 Apr 2011

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT01320683

/ TerminatedPhase 2IIT

A Phase II Trial of Radioimmunotherapy (Y-90 M5A) Following Hepatic Resection and FOLFIRI or FOLFOX Chemotherapy [+/-BEVACIZUMAB], or Xelox for Metastatic Colorectal Carcinoma to the Liver

This phase II trial studies how well giving combination chemotherapy and bevacizumab before surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving chemotherapy and monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery

Start Date01 Mar 2011

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT00645060

/ CompletedPhase 1IIT

A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies

RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for advanced cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.

Start Date09 Oct 2006

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with 90Y-DOTA-M5A

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100 Translational Medicine associated with 90Y-DOTA-M5A

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100 Patents (Medical) associated with 90Y-DOTA-M5A

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1

Literatures (Medical) associated with 90Y-DOTA-M5A

01 Feb 2020·Cancer biotherapy & radiopharmaceuticals

Phase I Study of Yttrium-90 Radiolabeled M5A Anti-Carcinoembryonic Antigen Humanized Antibody in Patients with Advanced Carcinoembryonic Antigen Producing Malignancies

Article

Author: Dean Lim ; Mihaela Cristea ; Jeffrey Y.C. Wong ; Yi-jen Chen ; David Akhavan ; Dave Yamauchi ; Kofi Poku ; Paul Yazaki ; Jennifer Simpson ; Paul H. Frankel ; James Bading ; John Shively ; Anna Wu ; David Colcher

Background::

M5A is a humanized monoclonal antibody (mAb) directed against carcinoembryonic antigen (CEA) The purpose of this first in human phase I dose-escalation trial was to characterize the toxicities and determine the maximum tolerated dose (MTD) of yttrium-90 ( 90 Y)-DOTA-M5A as a single agent and in combination with gemcitabine (gem).

Methods::

Patients with advanced metastatic CEA-producing malignancies who had progressed on standard therapies were first administered indium-111 ( 111 In)-DOTA-M5A. If tumor targeting was observed, the patient then received the therapy dose of 90 Y-DOTA-M5A. Serial scans, blood sampling, and 24 h urine collections were then performed to estimate radiation doses to organs and total body. Assays for human antihuman antibody (HAHA) responses were performed out to 6 months.

Results::

Of the 18 patients who received 111 In-DOTA-M5A, 16 received 90 Y-DOTA-M5A therapy; 1 patient at 14 mCi/m 2 with gem (150 mg/m 2 days 1and 3), 3 patients at 12 mCi/m 2 with gem, 6 patients at 12 mCi/m 2 without gem, and 6 at 10 mCi/m 2 without gem. Prolonged cytopenias resulted in discontinuation of dose escalation with gemcitabine. A single agent MTD of 10 mCi/m 2 was established based on dose-limiting hematopoietic toxicities. HAHA immune response was identified in 2 of 16 patients (12.5%). Stable disease at 3 months was seen in 10 patients and 2 patients demonstrated an 88% and 64% decrease in CEA back to normal levels. In 2 patients 111 In-DOTA-M5A imaging revealed previously unknown brain metastases.

Conclusion::

This study demonstrates the potential utility of the 90 Y-DOTA-M5A anti-CEA mAb as a therapeutic antibody. There is decreased immunogenicity compared with murine and chimeric mAbs, allowing for the potential of multiple administrations. Combined modality therapy approaches incorporating this agent should continue to be evaluated.

100 Deals associated with 90Y-DOTA-M5A

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Liver metastases	Phase 2	United States	City of Hope National Medical Center	01 Mar 2011
Metastatic Colorectal Carcinoma	Phase 2	United States	City of Hope National Medical Center	01 Mar 2011
Rectal Cancer	Phase 2	United States	City of Hope National Medical Center	01 Mar 2011
Recurrent Colon Cancer	Phase 2	United States	City of Hope National Medical Center	01 Mar 2011
Advanced Malignant Solid Neoplasm	Phase 1	United States	City of Hope National Medical Center	09 Oct 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00645060 (Pubmed) Manual	Phase 1	Neoplasms	34	gemcitabine+yttrium-90 (90Y)-DOTA-M5A	gojbclhpjn(gvalfrksot) = lyhtwhpnlr ajhnilvpnq (unllnhujsc ) View more	Positive	01 Feb 2020
NCT01320683 (CTgov)	Phase 2	Recurrent Colon Cancer \| Rectal Cancer \| Liver metastases ... View more	1	pharmacological study+yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A+Leucovorin Calcium+bevacizumab+oxaliplatin+irinotecan hydrochloride+fluorouracil	czlwtfxaik(nogtdfyqul) = qrrrhwmsym jdqribifns (pljpltwgfx, yyoiskscyx - llcljqwvxg) View more	-	20 Jun 2016

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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