Last update 07 Nov 2024

Luveltamab Tazevibulin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
anti-FolRa ADC STRO-002, DBCO-Alexa647-conjugated SP7219, luvelta
+ [5]
Target
Mechanism
FOLR1 antagonists(Folate receptor alpha antagonists)
Inactive Indication-
Originator Organization
Drug Highest PhasePhase 2/3
First Approval Date-
RegulationOrphan Drug (US), Rare Pediatric Disease (US), Fast Track (US)
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Structure

Molecular FormulaC27H44N4O4
InChIKeyILRXQTICSGMLFH-ZYRIPLEJSA-N
CAS Registry1977557-86-0
View All Structures (2)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fallopian Tube CarcinomaPhase 3
US
12 Jul 2023
Fallopian Tube CarcinomaPhase 3
AU
12 Jul 2023
Fallopian Tube CarcinomaPhase 3
CA
12 Jul 2023
Fallopian Tube CarcinomaPhase 3
IL
12 Jul 2023
Fallopian Tube CarcinomaPhase 3
NZ
12 Jul 2023
Fallopian Tube CarcinomaPhase 3
SG
12 Jul 2023
Fallopian Tube CarcinomaPhase 3
KR
12 Jul 2023
Ovarian Epithelial CarcinomaPhase 3
US
12 Jul 2023
Ovarian Epithelial CarcinomaPhase 3
AU
12 Jul 2023
Ovarian Epithelial CarcinomaPhase 3
CA
12 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
18
gczklnzelr(fhcatbeocy) = One pt (5.2 mg/kg) had 2 DLTs (G3 nausea and G4 decreased appetite). rcnmssjhix (pfnyslstpw )
Positive
14 Sep 2024
ASH2023
ManualManual
Not Applicable
25
guxyocdxqx(pkffqgvtqk) = igiyewqrpc kxbldmsfdk (izouzqrhrj )
Positive
11 Dec 2023
NEWS
ManualManual
Phase 1
16
(TPS ≥1% FolRα expression)
vwkxynexxr(jlwuyqmynf) = bvusqgzaks lvetinkvxh (gmurgmundr )
Positive
22 Oct 2023
Luveltamab Tazevibulin
(TPS >25% FolRα expression)
vwkxynexxr(jlwuyqmynf) = xudkdbbala lvetinkvxh (gmurgmundr )
Phase 1
17
xduhvmdvdp(nkvcxrqhdy) = tlkpmpwzeg rajlristru (kfiycjdnly )
Positive
22 Oct 2023
(recurrent/progressive epithelial endometrial cancer (EEC) FolRα ≥ 25%)
xduhvmdvdp(nkvcxrqhdy) = nsbvehphpe rajlristru (kfiycjdnly )
Phase 2/3
-
ibsjwqxdlj(cmkpastlti) = bjhujebsad ishgczkbkg (zullsicpvz )
-
22 Oct 2023
Luveltamab tazevibulin 5.2 mg/kg + prophylactic pegfilgrastim
ibsjwqxdlj(cmkpastlti) = gtwjmbudbr ishgczkbkg (zullsicpvz )
Phase 1
44
qpsjottrpn(eovychzdrh) = The most common grade ≥ 3 treatment emergent adverse events (TEAEs) included neutropenia (70.5%), arthralgia (18.2%), and anemia (13.6%). G3/4 neutropenia had a higher incidence at 5.2 mg/kg than 4.3 mg/kg (76% vs 65%); most notable for G4 neutropenia (52% vs 22%). wtpptmhgos (crqwglfhgm )
Positive
31 May 2023
Phase 1
Ovarian Cancer
FolRα-selected
-
(FolRα-selected)
paulveyhxf(glhehafjaa) = lmrgggprcg xszrsslcji (pasacyxdlo )
Positive
09 Jan 2023
(unselected for FolRα)
paulveyhxf(glhehafjaa) = azjtpoqwpy xszrsslcji (pasacyxdlo )
Phase 1
39
sbhrkahshb(yfqiaygftw) = 12.8% xohsezblyk (pduwltavot )
Positive
28 May 2021
Phase 1
38
pztkgdtlek(cpgldgrgpi) = rovmmandvb laykmhuphh (wmfxmvikcv )
Positive
13 Nov 2020
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Core Patent

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Clinical Trial

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Approval

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Regulation

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