CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Advanced Gastroesophageal Junction AdenocarcinomaCLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinoma+ [9]

Inactive Indication

AdenocarcinomaCLDN18.2 Positive Gastrointestinal NeoplasmsEsophageal Carcinoma+ [1]

Originator Organization

Ganymed Pharmaceuticals AG

Active Organization

Astellas Pharma Global Development, Inc.Astellas Pharma Europe BV

Astellas Pharma China, Inc.

+ [5]

Inactive Organization

Ganymed Pharmaceuticals AG

License Organization

Shanghai Pharmaceutical Co., Ltd.

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (26 Mar 2024),

CLDN18.2 positive Stomach Cancer

RegulationPriority Review (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Accelerated assessment (United States)

Structure/Sequence

Sequence Code 431594752L

Source: *****

Sequence Code 524309292H

Source: *****

Clinical Trials associated with Zolbetuximab

NCT06962137

/ Not yet recruitingPhase 2IIT

Phase II RAINSPOT: a Multicentric Open Label Trial of Zolbetuximab-Paclitaxel-Ramucirumab in Second Line Setting for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma

This study examines whether adding the drug Zolbetuximab to an existing treatment (Paclitaxel and Ramucirumab) can improve patients' survival. The goal is to see if this combination works better for patients whose tumours contain a specific protein (CLDN18.2). The results will be compared to past patient data from those who only received the standard treatment.
Zolbetuximab (Vyloy) is a cancer medicine that is used to treat adults with gastric or gastro-esophageal junction adenocarcinoma (a type of cancer of the stomach or the transition between the stomach and esophagus). Zolbetuximab will be administered via an intravenous infusion in combination with Paclitaxel and Ramucirumab (Cyramza) (two other cancer drugs that are the standard treatment for this condition). Treatment will take place at regular intervals in the hospital. In addition to treatment,patients will undergo a tumour biopsy. While the biopsy procedure may cause some discomfort or pain, it will only be performed if medically justifiable. Patients participation in the study will continue as long as they receive treatment and the disease does not worsen. The overall duration of the study, for all patients, will span several years.

Start Date01 Oct 2025

Sponsor / Collaborator-

NCT06901531

/ RecruitingPhase 3

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Start Date22 May 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06881017

/ Not yet recruitingPhase 2IIT

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

Start Date01 May 2025

Sponsor / Collaborator

China Medical University

100 Clinical Results associated with Zolbetuximab

100 Translational Medicine associated with Zolbetuximab

100 Patents (Medical) associated with Zolbetuximab

113

Literatures (Medical) associated with Zolbetuximab

01 Jun 2025·EUROPEAN JOURNAL OF CANCER

Navigating the clinical challenges of zolbetuximab in patients with claudin positive advanced gastric cancer

Review

Author: Gervaso, L ; Fazio, N ; Cella, C A ; Rosanu, N M

Zolbetuximab, a first-in-class monoclonal antibody targeting Claudin 18.2 (CLDN 18.2), has demonstrated significant survival benefit when combined with chemotherapy in HER2-negative, CLDN 18.2-positive advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. However, its integration into clinical practice presents two major challenges: the best treatment selection between zolbetuximab or immune checkpoint inhibitor (ICI)-based regimens in patients co-expressing programmed death-ligand 1 (PD-L1), and the management of zolbetuximab-related nausea and vomiting (N/V). We critically reviewed evidence from randomized controlled trials, regulatory approvals, and recent expert consensus on zolbetuximab management. In CLDN 18.2-positive/PD-L1-positive patients, ICIs may offer greater long-term survival benefit especially in case of high PD-L1 CPS, while zolbetuximab may be preferred in patients with negative-to-low CPS or ICIs contraindications. N/V, reported in more than three-quarter of patients, is more frequent and severe during the first infusion, due to zolbetuximab loading dose and faster infusion rate. Proper management includes accurate adherence to high-risk antiemetic protocols (including NK-1/5-HT3 antagonists and corticosteroids) and careful control of infusion rates with a stop and go strategy. In case of CLDN 18.2 and PD-L1 CPS co-positivity, we advocate the use of PD-L1 CPS ≥ 10 as a practical decision-making threshold for favoring ICI-based regimens. However, the treatment selection should be tailored on comorbidities, comprehensive molecular characterization and available subsequent options. To ensure the optimal use of zolbetuximab, special attention is required during the first cycle, due to higher risk of infusion-related N/V. We suggest that the optimization of both prophylactic and on-treatment antiemetic strategies is essential to enhance zolbetuximab adherence and maximize clinical outcomes.

30 May 2025·Oncology Research and Treatment

Guidelines of Onkopedia: What is new? Esophageal Cancer.

Review

Author: Moehler, Markus ; Lorenzen, Sylvie ; Thuss-Patience, Peter ; Köberle, Dieter ; Götze, Thorsten O ; Stuschke, Martin ; Porschen, Rainer ; Grenacher, Lars ; Wörmann, Bernhard ; Gockel, Ines ; Scheck, Magdalena K ; Al-Batran, Salah-Eddin ; Pritzkuleit, Ron ; Maschmeyer, Georg ; Sinn, Marianne ; Hass, Holger G ; Rumpold, Holger ; Borner, Markus

This article presents new relevant aspects of the recently updated German, Swiss, Austrian Onkopedia guideline for the treatment of esophageal cancer. The full guideline can be accessed at https://www.onkopedia-guidelines.info/en/onkopedia/guidelines/esophageal-cancer/@@guideline/html/index.html. All rights for the use of text sections and Figures have been obtained. The most important aspects in the perioperative treatment of resectable esophageal adenocarcinoma include the recommendation for the use of perioperative chemotherapy with FLOT as it was shown superior to preoperative chemoradiotherapy analogous CROSS in the ESOPEC trial. Furthermore, there is increasing evidence for the effectivity of targeting therapy and immune checkpoint inhibition in certain molecular defined subgroups. Immune checkpoint inhibition is recommended in combination with perioperative chemotherapy (FLOT) for MSI-H tumors, whereby the treatment should preferably take place in studies. In the metastatic setting, the approval for the PD-1 inhibitor tislelizumab was extended to the first-line treatment of both, squamous cell- and adenocarcinoma of the esophagus (TAP score (≥ 5%) and for second line for squamous-cell cancer only (independent of PD-L1 expression). Moreover, for gastroesophageal junction (GEJ) tumors, pembrolizumab is available upon PD-L1 expression (CPS ≥ 1) according to the data of the KEYNOTE-859 trial. In addition to the established biomarkers HER2 und PD-L1, Claudin 18.2 represents now a new targetable option. First-line chemotherapy is to be combined with zolbetuximab in Claudin 18.2 positive GEJ tumors. For biomarker-negative adenocarcinomas of the esophagus and esophago-gastric junction (GEJ), a modified triplet regimen (TFOX) is a newly presented treatment option. Because of high toxicity rates and yet unclear survival benefit this option is only recommended for docetaxel-naïve patients with high remission pressure.

05 May 2025·MOLECULAR PHARMACEUTICS

Targeted Radionuclide Therapy of CLDN18.2-Positive Gastric Cancer with [¹³¹I]I-Zolbetuximab: An In Vitro and In Vivo Study

Article

Author: Liu, Yuxia ; Li, Qingnuan ; Wang, Yang ; Ma, Lin ; Mu, Chao ; Yang, Jian ; He, Shuhua ; Li, Zheng ; Kuang, Zijun

Radiopharmaceuticals are a promising therapeutic strategy for tumors with less reduced resistance and minimal side effects. In our previous study, we radiolabeled the monoclonal antibody zolbetuximab, which targets CLDN18.2, with ¹²⁵I, and the labeled compound showed favorable tumor targeting and retention. In this research article, [¹³¹I]I-zolbetuximab was prepared to investigate its therapeutic effect on gastric cancer using in vitro and in vivo studies. The zolbetuximab was radiolabeled with ¹³¹I using the Iodogen method. The uptake mechanism of [¹³¹I]I-zolbetuximab was investigated through an endocytosis experiment using MKN45-CLDN18.2 and MKN45 cells. The safety assessment of [¹³¹I]I-zolbetuximab was conducted in normal mice using hematoxylin/eosin (H&E) staining. The tumor uptake, biodistribution, and therapeutic efficacy of [¹³¹I]I-zolbetuximab were evaluated in nude mice bearing MKN45-CLDN18.2 tumors, while the hematological analysis, immunohistochemistry, Western blotting (WB), immunofluorescence, and H&E assays were used to further assess the treatment response and toxicity. [¹³¹I]I-Zolbetuximab exhibited a high labeling efficiency of (96.05 ± 0.23)%, a specific activity of 1.75 × 10² GBq/μmol, and good in vitro stability. The binding of [¹³¹I]I-zolbetuximab to the membrane surface receptors of MKN45-CLDN18.2 cells resulted in significant tumor uptake, retention, and favorable biodistribution in CLDN18.2-positive tumor-bearing nude mice. Safety assessments, including H&E staining, indicated no significant damage to normal mouse organs caused by the labeled compounds. In a therapeutic study involving MKN45-CLDN18.2 tumor-bearing nude mice, increasing drug dose led to notable enhancements in therapeutic efficacy and survival rates. H&E staining of mouse organs at the end of treatment showed no significant toxicity was observed across all dose groups throughout the treatment period. Furthermore, immunohistochemistry, immunoblotting, and immunofluorescence analyses conducted on mouse tumors at the treatment end point demonstrated a reduction in CLDN18.2 expression following treatment. Altogether, [¹³¹I]I-zolbetuximab displayed exceptional targeting capability, tumor retention property, significant therapeutic efficacy, and safety. These findings suggest its potential to serve as a targeted radiopharmaceutical for the treatment of CLDN18.2-positive gastric cancer.

101

News (Medical) associated with Zolbetuximab

06 Jun 2025

·www.fiercepharma.com

Fierce Pharma Asia—Bispecific field's roller coaster week; Enhertu's first-line win; Regeneron-Hansoh obesity deal

Summit Therapeutics' unsatisfactory global phase 3 readout, Bristol Myers Squibb's big bet on PD-L1/VEGF, Enhertu's first-line breast cancer data and Regeneron's obesity deal with Hansoh Pharma made our news this week. The PD-(L)1xVEGF field had a roller coaster week marked by an imperfect readout and a potentially $11 billion deal. AstraZeneca and Daiichi Sankyo trotted out Enhertu's detailed data in first-line breast cancer. Regeneron signed on a GLP-1/GIP candidate from China's Hansoh Pharma. And more.1. Akeso, Summit's ivonescimab delayed progression of certain lung cancers in first global phase 3 readoutBristol Myers inks $11B BioNTech deal to join bispecific gold rush, leaping ahead of Merck and PfizerSummit Therapeutics unveiled the first global phase 3 readout from Akeso’s PD-1xVEGF bispecific ivonescimab, saying the drug reduced the risk of progression or death by 48% in previously treated EGFR-mutated nonsquamous non-small cell lung cancer. But, because the HARMONi trial did not meet the overall survival endpoint at the current analysis, the company’s stock price tanked.But the PD-(L)1xVEGF field quickly got an injection of confidence when Bristol Myers Squibb announced a potentially $11.1 billion deal to co-develop and co-commercialize BioNTech’s PD-L1xVEGF candidate BNT327. The deal includes $1.5 billion upfront and $2 billion in unconditional anniversary payments through 2028. BioNTech got the drug recently from purchasing its then-partner, Chinese biotech Biotheus, for $800 million upfront.2. ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer dataAstraZeneca and Daiichi Sankyo’s Enhertu, used in combination with Roche’s Perjeta, significantly reduced the risk of progression or death by 44% versus the standard THP regimen in first-line HER2-positive breast cancer. Experts suggested that the result, from the Destiny-Breast09 trial, makes the Enhertu combo a new first-line standard treatment option, although some questions such as treatment duration remained.3. Regeneron pens $2B pact for Hansoh's potential obesity rival to Lilly's ZepboundRegeneron is paying China’s Hansoh Pharma $80 million upfront for ex-China rights to a GLP-1/GIP receptor agonist coded HS-20094. The deal includes up to $1.93 billion in potential milestone payments. The drug is currently undergoing a phase 2b in diabetes and a phase 3 in obesity in China.4. Astellas aspires to strike CLDN18.2 gold again with ADC licensing deal worth up to $1.34BAstellas has doubled down on the Claudin18.2 field by in-licensing an antibody-drug conjugate from Chinese biotech Evopoint Biosciences in a deal potentially worth up to $1.34 billion. Evopoint is testing the agent, XNW27011, in a phase 1/2 solid tumor trial covering gastric, pancreatic, colorectal, ovarian and other cancers. Astellas already has the first FDA-approved Claudin18.2 agent, Vyloy.5. Cullinan pens $700M pact for BCMA bispecific to pair with another autoimmune T-cell engagerCullinan Therapeutics, which is already working on a CD19 bispecific for autoimmune diseases, is getting a BCMA T-cell engager. For $20 million upfront and nearly $700 million in potential milestones, Cullinan is getting ex-China rights to Genrix Bio’s BCMAxCD3 candidate velinotamig. Last year, researchers reported a deep remission in a woman with aggressive refractory systemic lupus erythematosus who received Johnson & Johnson’s BCMA bispecific Tecvayli.6. Kelun-Biotech raises $250M with 6M share placement (release)After its Hong Kong IPO in 2023, China's Kelun-Biotech has raised about $250 million in a new share placement. The company sold about 5.92 million shares at HK$331.80 per share, according to a press release. Kelun said the placement was "multiple times oversubscribed" with support from various types of investors, leading the biotech to expand a previous fundraising target of $200 million. Kelun plans to use the money to fund R&D operations, regulatory interactions, manufacturing infrastructure and more. Other News of Note:7. Ascletis scores phase 3 win for daily acne pill, prepares push to Chinese regulators8. ASCO: Kura, Kyowa reveal 23% remission rate behind oral leukemia drug's phase 2 win9. BioAge inks option agreement for Chinese biotech's obesity asset on heels of earlier APJ agonist setback10. Astellas organizes action week to connect patients to advocacy groups11. Fujifilm, Coherus, ViGeneron unveil rebrands to better reflect ongoing work

Phase 3Phase 2Drug ApprovalClinical ResultLicense out/in

30 May 2025

·firstwordpharma.com

Astellas strikes $1.34B deal with Evopoint for CLDN18.2-directed ADC

Looking to bulk up its oncology pipeline, Astellas Pharma signed a licensing deal worth nearly $1.4 billion with Evopoint Biosciences for rights to the latter’s investigational antibody-drug conjugate (ADC) targeting CLDN18.2, dubbed XNW27011.The agreement announced Thursday, grants Astellas exclusive development and commercialisation rights to XNW27011 worldwide, with the exception of mainland China, Hong Kong, Macao and Taiwan. Evopoint will receive $130 million upfront, up to $70 million in near-term payments and additional milestone payments totalling up to $1.34 billion, plus sales royalties.The ADC — which utilises topoisomerase I inhibitor payload and linker technology — is currently undergoing Phase I/II trials for CLDN18.2-expressing solid tumours in China, including gastric, gastroesophageal and pancreatic cancers. “We look forward to harnessing our expertise in targeting CLDN18.2 and specialised knowledge in [gastrointestinal] cancers to advance XNW27011 and deliver meaningful outcomes to patients," Adam Pearson, chief strategy officer at Astellas.XNW27011 represents a strategic addition to Astellas' portfolio, which already includes Vyloy (zolbetuximab), the world's first approved CLDN18.2-targeted therapy approved for first-line gastric cancer in Japan, the EU and US. The Japanese drugmaker recently touted “greater-than-expected sales growth" of Vyloy.

ADCLicense out/inDrug ApprovalPhase 1

30 May 2025

·www.prnewswire.com

Astellas Enters Exclusive License Agreement with Evopoint Biosciences for XNW27011, a Novel Clinical-stage Antibody-Drug Conjugate Targeting CLDN18.2

- Agreement grants Astellas exclusive worldwide rights (excluding China's mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 - - XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study of patients with solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer - - Evopoint to receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved - TOKYO and SUZHOU, China, May 29, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) today announced they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. The agreement grants Astellas a worldwide (excluding China's mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011. XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies. Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOYTM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient need and will expand Astellas' oncology pipeline which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADC's directed to other targets. Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved. Adam Pearson, Chief Strategy Officer, Astellas "Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. XNW27011 is a promising new asset that complements Astellas' pipeline and enhances our leading position in precision oncology. We look forward to harnessing our expertise in targeting CLDN18.2 and specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients." Arthur Qiang , Chairman , Evopoint "XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic. Astellas has a proven history of developing and commercializing a strong franchise of innovative cancer therapies. We are pleased to enter into this new license agreement to further our collective goals of bringing new treatment options for patients in need worldwide." About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . About Evopoint Biosciences Evopoint Biosciences is an innovative biopharmaceutical company with exceptional capabilities in R&D and commercialization. Since its inception, Evopoint has been committed to improving human health by discovering and developing cutting-edge pharmaceutical solutions that address significant unmet medical needs worldwide. Leveraging diverse discovery platforms in targeted therapy, ADC, and targeted protein degradation (TPD), the company has built a robust pipeline focused on oncology, infectious diseases and metabolic diseases. Learn more at . Astellas Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. SOURCE Astellas Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inADC

100 Deals associated with Zolbetuximab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Zolbetuximab	-	DB15118

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Canada	Astellas Pharma Canada, Inc.	09 Jan 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive stomach adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive Stomach Cancer	Japan	Astellas Pharma, Inc.	26 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Japan	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Argentina	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Canada	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Croatia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Greece	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Ireland	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Malaysia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Netherlands	Astellas Pharma Global Development, Inc.	28 Nov 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	Phase 3	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	beugrtycsd(aemdwjqlvb) = cqqorjovjs tnicvfdbzo (ngowbmzmmv, zwutkwtznr - lbrhxpnfkw) View more	-	26 Feb 2025
NCT03653507 (GLOW, CTgov)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	lwnlwtsjem(vhotsporwe) = raakbypgai cvkhbgowcb (brtzknprfd, ufelqdjflw - ykjcnwalpj) View more	-	27 Jan 2025
				Placebo (CAPOX+ Placebo)	lwnlwtsjem(vhotsporwe) = xlalojbfvs cvkhbgowcb (brtzknprfd, rripntveeo - cxbvosniby) View more
NCT03653507 (GLOW, NEWS) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	oaajlmosbz(bjqkpcybmg) = kallimuayl jqydblpsnb (dbrmlrkaib, 6.1 - 9.1) View more	Positive	28 Sep 2024
				安慰剂联合CAPOX	oaajlmosbz(bjqkpcybmg) = vocmcdkpxl jqydblpsnb (dbrmlrkaib, 5.0 - 8.0) View more
NCT03504397 (SPOTLIGHT, NEWS) Manual	Phase 3	Gastroesophageal junction adenocarcinoma First line CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	knszqobsiz(mzcddmipxu) = rubzzvdxzn qgyqgafrdx (pvjemsmxpc, 6.7 - 16.7) View more	Positive	28 Sep 2024
				安慰剂+mFOLFOX6	knszqobsiz(mzcddmipxu) = jjvjmarokq qgyqgafrdx (pvjemsmxpc, 6.0 - 8.4) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	bovqloqvna(bnmhetqlhs) = qwshppkwdc fdpjwkkpil (iuiigtfefm, 8.4 - 10.4) View more	Positive	16 Sep 2024
				Placebo + chemotherapy	bovqloqvna(bnmhetqlhs) = jxmycdfswu fdpjwkkpil (iuiigtfefm, 7.6 - 8.4) View more
NCT03504397 (SPOTLIGHT, ASCO2024) Manual	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	vgivrthuiy(uojxfrxcej) = bqbfhhwfiq esvjwpcxfe (tkgjeafyok ) View more	Positive	24 May 2024
				Placebo + mFOLFOX6	vgivrthuiy(uojxfrxcej) = kibbzvxzug esvjwpcxfe (tkgjeafyok ) View more
NCT03653507 \| NCT03504397 (Pubmed \| Future Oncol)	Phase 3	Gastrooesophageal junction cancer CLDN18.2-positive \| HER2-negative	-	Zolbetuximab plus chemotherapy	plcnctogri(ildqpqwmld) = vpmrmcbgpk fhwopspmpw (siqutfptfj ) View more	Positive	24 May 2024
				Placebo plus chemotherapy	plcnctogri(ildqpqwmld) = cuoaxksnxd fhwopspmpw (siqutfptfj ) View more
NCT04086758 \| NCT03653507 \| NCT00909025 \| NCT03504397 \| NCT03505320 \| NCT01630083 \| NCT03528629 \| NCT01197885 \| NCT01671774 (ASCO_GI2024) Manual	Not Applicable	Adenocarcinoma of Esophagus \| CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2 Positive	-	Zolbetuximab (First Dose (800 mg/m2))	hymhkfswhn(lqnesjuxrg) = xrwjhklwnk dffbmszkwh (qtrphkvsbr, 96) View more	Positive	18 Jan 2024
				Zolbetuximab (Steady State (600 mg/m2 Q3W))	hymhkfswhn(lqnesjuxrg) = suomchrxan dffbmszkwh (qtrphkvsbr, 91) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT, ASCO_GI2024) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	-	Zolbetuximab + mFOLFOX6	umsqlibnti(dccnftkyuo) = olwztaligb edrkhaubgx (aepupdklkz ) View more	Positive	18 Jan 2024
				Zolbetuximab + CAPOX	umsqlibnti(dccnftkyuo) = oszlihacff edrkhaubgx (aepupdklkz ) View more
NCT03504397 (SPOTLIGHT study, ESMO_ASIA2023)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2−	565	Zolbetuximab + mFOLFOX6	xnskmnqsis(tdheaedliv) = vbpehitbwp nxzdewrpeb (clcgiroxil ) View more	Positive	03 Dec 2023
				Placebo + mFOLFOX6	xnskmnqsis(tdheaedliv) = qlfrailrdv nxzdewrpeb (clcgiroxil ) View more

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