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https://go.drugbank.

com/drugs/DB13007

Brentuximab ClinicalTrials.gov Identifier: NCT03646123


Brentuximab is a type of targeted cancer drug called a monoclonal antibody .

It is also known by its full name brentuximab vedotin and its brand name Adcetris.

It is a treatment for:

• Hodgkin lymphoma
• a type of non Hodgkin lymphoma called anaplastic large cell lymphoma (ALCL)
• cutaneous T cell lymphoma

How does brentuximab work?


Brentuximab is a type of monoclonal antibody. Monoclonal antibodies (MABs) are copies of a
single antibody. They are made in the laboratory. Monoclonal antibodies seek out cancer cells by
targeting particular proteins on the cell surface.

Brentuximab targets a protein called CD30 that is found on Hodgkin lymphoma and anaplastic
large cell lymphoma cells. Brentuximab sticks to the CD30 protein and delivers a drug to the cell.
The drug then kills the cell.

Target

brentuximab vedotin (Adcetris), which targets the CD30 antigen found on B cells and
T cells. The antibody is attached to a chemotherapy drug called monomethyl
auristatin E (MMAE). It is used to treat Hodgkin’s lymphoma and anaplastic large
cell lymphoma.

Side effects

Nausea, vomiting, diarrhea, dizziness, headache, or unusual tiredness may occur.

MOA

Brentuximab vedotin is composed of 3 parts: a chimeric human-murine IgG1 that


selectively targets CD30, monomethyl auristatin E (MMAE), which is a microtubule-
disrupting agent, and a protease-susceptible linker that links the antibody and
MMAE. The IgG1 antibody enables Brentuximab vedotin to target tumor cells
expressing CD30 on their surface. Following this Brentuximab vedotin enters the
cell. Once inside, the linker is cleaved releasing MMAE which binds disrupts the
microtubule network.13

The antibody component of this drug is a chimeric IgG1 directed against CD30. The
small molecule, MMAE, is a microtubule-disrupting particle. MMAE is covalently
attached to the antibody by a linker. Data suggest that the anticancer activity of
Adcertris is due to the binding of the ADC to CD30-expressing cells, followed by
internalization of the ADC-CD30 complex, and the subsequent release of MMAE by
proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network
within the cell, inducing cell cycle arrest and apoptotis of the malignant cells Label.

TARGET ACTIONS
ATumor necrosis factor receptor superfamily member 8 binder
antibody
regulator
Enfortumab
ClinicalTrials.gov Identifier: NCT04223856

Enfortumab vedotin-ejfv is a type of drug called an antibody-drug conjugate. Antibody-


drug conjugates consist of a monoclonal antibody chemically linked to a cancer-killing
drug. The monoclonal antibody binds to a protein on the surface of some cancer cells.
The linked drug enters these cancer cells and kills them. Enfortumab vedotin-ejfv may
also stimulate the immune system to kill cancer cells. It is a type of targeted therapy.

Use in Cancer
Enfortumab vedotin-ejfv is approved to treat:

Urothelial cancer (a type of cancer in the bladder or urinary tract) that has
spread. It is used:
o Alone in adults whose cancer cannot be removed by surgery and
who have received platinum chemotherapy and immunotherapy.
o Alone in adults whose cancer cannot be removed by surgery and
who have received at least one other type of treatment and
cannot receive cisplatin.
o With pembrolizumab in adults who cannot receive cisplatin.

Enfortumab vedotin-ejfv is also being studied in the treatment of other types of


cancer.

Target: Enfortumab is comprised of an antibody targeting nectin-4,


widely expressed in urothelial cancers, with an monomethyl
auristatin E (MMAE) chemotherapy payload.

MOA

Enfortumab vedotin is an antibody-drug conjugate (ADC) comprised


of a human IgG1 antibody directed against Nectin-4 linked to
monomethyl auristatin E (MMAE), a microtubule-disrupting agent
(Astellas Pharma US, Inc., 2019). The anticancer activity of enfortumab
vedotin is due to the binding of the ADC to Nectin-4–expressing cells,
followed by internalization of the ADC-Nectin-4 complex, and the
release of MMAE via proteolytic cleavage. Monomethyl auristatin E
activity induces cell cycle arrest and apoptotic cell death.

( Enfortumab vedotin is an antibody-drug conjugate comprised of multiple


components.3 It contains a fully human monoclonal antibody directed against Nectin-
4, an extracellular adhesion protein which is highly expressed in urothelial
cancers,1 attached to a chemotherapeutic microtubule-disrupting agent, monomethyl
auristatin E (MMAE). These two components are joined via a protease-cleavable
linker. Enfortumab vedotin binds to cells expressing Nectin-4 and the resulting
enfortumab-Nectin-4 complex is internalized into the cell. Once inside the cell,
MMAE is released from enfortumab vedotin via proteolytic cleavage and goes on to
disrupt the microtubule network within the cell, arresting the cell cycle and ultimately
inducing apoptosis.3

TARGET ACTIONS ORGAN


UNectin-4 binder Humans
antibody

Side effects

• Blurred vision
• burning, dry, or itching eyes
• burning, numbness, tingling, or painful sensations
• discharge, excessive tearing
• dry eyes
• dry mouth
• eye redness, irritation, or pain
• flushed, dry skin
• fruit-like breath odor
• increased hunger, thirst, urination
• lack or loss of strength
• nausea
• rash with flat lesions or small raised lesions on the skin
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• stomach pain
• sweating
• trouble breathing
• unexplained weight loss
• unsteadiness or awkwardness
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet
NCT Number: The National Clinical Trial number is an identification
that ClinicalTrials.gov assigns a study when it is registered. The
NCT number is in the format “NCTXXXXXXXX”. Until an NCT
number is assigned, the study is not registered.

Mission
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials
conducted in India are prospectively registered, i.e. before the enrolment of the first
participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as
clinical studies as part of PG thesis are also expected to be registered in the CTRI.

Chinese Clinical Trial


Registry (ChiCTR)
中国临床试验注册中心
Registry Profile

General Information

Address:
No. 37
Guo Xue Xiang, Chengdu
China

Registry URL: http://www.chictr.org.cn

Registration URL: http://www.medresman.org/login.aspx

Email: chictr@scu.edu.cn

Partner Registries with which this Primary Registry is affiliated:


Centre for Clinical Trials, Clinical Trials Registry - Chinese University of Hong Kong
Since 2007, the International Committee of Medical Journal Editors (ICMJE) accepts all primary
registries in the WHO network in addition to clinicaltrials.gov. The complete list from the ICMJE is
as follows:

• Australia and New Zealand's (ANZCTR)


• Brazilian Clinical Trials Registry (ReBec)
• Chinese Clinical Trial Registry (ChiCTR)
• Clinical Research Information Service (CRiS), Republic of Korea
• Clinical Trials Registry - India (CTRI)
• Cuban Public Registry of Clinical Trials (RPCEC)
• EU Clinical Trials Register (EU-CTR)
• German Clinical Trials Register (DRKS)
• Iranian Registry of Clinical Trials (IRCT)
• Japan Primary Registries Network
• The Netherlands Trial Register
• Pan African Clinical Trial Registry (PACTR)
• Peruvian Registry of Clinical Trials
• Philippine Health Research Registry
• Sri Lanka Clinical Trials Registry (SLCTR)
• South African National Clinical Trials Register
• Swiss FOPH Human Research Projects
• Tanzania Clinical Trial Registry
• Thai Clinical Trials Registry
• The United Kingdom's ISRCTN registry
• The United States' ClinicalTrials.gov

References[edit]
1. ^ "ANZCTR". www.anzctr.org.au.
2. ^ Jump up to:a b "WHO - China and India join WHO clinical trial registry
platform". www.who.int. Archived from the original on August 14, 2007.
3. ^ "WHO - RPCEC (Cuban Public Registry of Clinical Trials)". www.who.int. Archived
from the original on July 5, 2011.
4. ^ "WHO - German Clinical Trials Register (GermanCTR)". www.who.int. Archived from the
original on October 21, 2012.
5. ^ "WHO - Iranian Registry of Clinical Trials (IRCT)". www.who.int. Archived from the
original on July 14, 2011.
6. ^ "WHO - Japan Primary Registries Network (JPRN)". www.who.int. Archived from the
original on October 21, 2012.
7. ^ "The Department of Health". Archived from the original on 2010-07-24. Retrieved 2010-
07-23.
8. ^ "WHO - Clinical Research Information Service (CRiS), Republic of Korea". www.who.int.
Archived from the original on October 21, 2012.
9. ^ "WHO - Sri Lanka Clinical Trials Registry (SLCTR)". www.who.int. Archived from the
original on October 21, 2012.
10. ^ Hartung, DM; Zarin, DA; Guise, JM; McDonagh, M; Paynter, R; Helfand, M
(2014). "Reporting discrepancies between the ClinicalTrials.gov results database and
peer-reviewed publications". Ann Intern Med. 160 (7): 477–483. doi:10.7326/m13-
0480. PMC 4617780. PMID 24687070
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