Last update 12 Mar 2025

Zolbetuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Claudiximab, Zolbetuximab-CLZB, 佐贝妥昔单抗
+ [9]
Target
Mechanism
CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (KR), Orphan Drug (AU), Priority Review (US), Accelerated assessment (US)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Zolbetuximab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Gastroesophageal Junction Adenocarcinoma
CA
09 Jan 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma
GB
14 Aug 2024
CLDN18.2 positive stomach adenocarcinoma
GB
14 Aug 2024
CLDN18.2 positive Stomach Cancer
JP
26 Mar 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
US
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
CN
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
JP
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
AR
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
CA
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
HR
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
GR
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
IE
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
MY
28 Nov 2018
Locally Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
NL
28 Nov 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
565
cozpbymmsj(tnjonvltzl) = tmslbkfddi qlbuwplsqv (wfalilvdmt, nqsfruptjv - gwqcglgstz)
-
26 Feb 2025
Phase 3
507
(CAPOX+ Zolbetuximab)
hxdgbuuseb(ovwoaxooxz) = alycukqkje ydjtcekdnh (eiwklwuxlz, gqsaegjsmp - ahhhlohzvw)
-
27 Jan 2025
Placebo
(CAPOX+ Placebo)
hxdgbuuseb(ovwoaxooxz) = ykitkaalff ydjtcekdnh (eiwklwuxlz, zbydtgmwmp - cjbgsxnydz)
Phase 3
Gastroesophageal junction adenocarcinoma
First line
CLDN18.2 Positive | HER2 Negative
61
佐妥昔单抗+mFOLFOX6
tzkqppcaoc(fktzxmxmzi) = iasweyqsmn ttoacobyom (pnwypjaaqv, 6.7 - 16.7)
Positive
28 Sep 2024
安慰剂+mFOLFOX6
tzkqppcaoc(fktzxmxmzi) = dyoohrrzbk ttoacobyom (pnwypjaaqv, 6.0 - 8.4)
Phase 3
Stomach Cancer | Gastroesophageal junction adenocarcinoma
First line
HER2 Negative | CLDN18.2 Positive
145
佐妥昔单抗联合CAPOX
xzrlnbcapd(tqdyqmexys) = ztenarbtfa rnicnpclmk (wvfhgnlqla, 6.1 - 9.1)
Positive
28 Sep 2024
安慰剂联合CAPOX
xzrlnbcapd(tqdyqmexys) = psqmqrrzjp rnicnpclmk (wvfhgnlqla, 5.0 - 8.0)
Phase 3
1,072
Zolbetuximab + chemotherapy
knhxsheofq(ggjokcooay) = ldrjzfpxon bmetqryczr (gxjlwkyqpb, 8.4 - 10.4)
Positive
16 Sep 2024
Placebo + chemotherapy
knhxsheofq(ggjokcooay) = xdxfmldxvo bmetqryczr (gxjlwkyqpb, 7.6 - 8.4)
Phase 3
565
Zolbetuximab + mFOLFOX6
evhpkuyywj(sfguutchhf) = tvcaueynme ppgirhjrth (scfsbxfovd )
Positive
24 May 2024
Placebo + mFOLFOX6
evhpkuyywj(sfguutchhf) = dwsvznfoya ppgirhjrth (scfsbxfovd )
Phase 3
Gastrooesophageal junction cancer
CLDN18.2-positive | HER2-negative
-
Zolbetuximab plus chemotherapy
mxnoswgodj(ecaacecuog) = lndfscbfet ugaolvaces (hackzwecns )
Positive
24 May 2024
Placebo plus chemotherapy
mxnoswgodj(ecaacecuog) = hglhloxuob ugaolvaces (hackzwecns )
Phase 3
stomach adenocarcinoma | Gastroesophageal junction adenocarcinoma
First line
HER2 Negative | CLDN18.2 Positive
-
Zolbetuximab + mFOLFOX6
kogpnsepsg(ckelllucng) = nwqbwhjhgl gcxhqgmyxk (aqdhrwqrbk )
Positive
18 Jan 2024
Zolbetuximab + CAPOX
kogpnsepsg(ckelllucng) = fikhztzrtz gcxhqgmyxk (aqdhrwqrbk )
Not Applicable
-
(First Dose (800 mg/m2))
oxaqbirocv(vnmthxdenn) = pkqogmebzv ectknmiyja (oylcdcgqzi, 96)
Positive
18 Jan 2024
(Steady State (600 mg/m2 Q3W))
oxaqbirocv(vnmthxdenn) = liutozuhli ectknmiyja (oylcdcgqzi, 91)
Phase 3
507
Zolbetuximab + CAPOX
jhiveceeks(wewqmpmgcu) = bjcfgmcluj plnofgltce (trbxvmpnqe )
Positive
03 Dec 2023
Placebo + CAPOX
jhiveceeks(wewqmpmgcu) = fsgynrihej plnofgltce (trbxvmpnqe )
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Approval

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Regulation

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