Delving into the Latest Updates on Zolbetuximab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Claudiximab, Zolbetuximab-CLZB, 佐贝妥昔单抗

+ [9]

Target

CLDN18.2

Action

inhibitors

Mechanism

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 BVAstellas Pharma Korea, 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), Accelerated Approval (United States), Orphan Drug (South Korea), Orphan Drug (Australia)

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Structure/Sequence

Sequence Code 431594752L

Source: *****

Sequence Code 524309292H

Source: *****

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

Start Date24 Sep 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

JPRN-jRCTs071250038

/ RecruitingPhase 2IIT

Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy

Start Date03 Sep 2025

Sponsor / Collaborator-

100 Clinical Results associated with Zolbetuximab

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100 Translational Medicine associated with Zolbetuximab

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100 Patents (Medical) associated with Zolbetuximab

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164

Literatures (Medical) associated with Zolbetuximab

01 Apr 2026·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

Author: Yoshioka, Tsubasa ; Kimura, Rika ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Tachibana, Ayu ; Okamoto, Risa

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

28 Mar 2026·Future Oncology

Zolbetuximab for gastroesophageal adenocarcinoma: drug review and lessons from the frontlines

Review

Author: Rogers, Jane E. ; Aune, Hannah ; Mathew, Shiba ; Sobocinski, Stacey ; Ajani, Jaffer A. ; Leung, Michael ; Covert, Wendy M. ; Esmaily-Fard, Amin ; Gulbis, Alison M.

Molecular distinctions have started to define treatment decisions in advanced gastric adenocarcinoma (GAC) and gastroesophageal junction adenocarcinoma (GEJAC), malignancies in need of improved outcomes. Claudin 18.2 (CLDN18.2) represents a new selective GAC/GEJAC target, with multiple agents currently in the developmental pipeline. Zolbetuximab, an anti-CLDN18.2 monoclonal antibody, is the first agent to market for this target. It received FDA approval following Phase III trials in which zolbetuximab combined with upfront fluoropyrimidine plus platinum therapy resulted in improved coveted endpoints compared to fluoropyrimidine plus platinum alone in CLDN18.2 positive advanced GAC patients (2+ or 3+ intensity in ≥75% of tumor cells). The most common adverse events are gastrointestinal, primarily nausea and vomiting during initial treatment cycles, particularly in those with an intact stomach (i.e. no prior surgery). Real-world implementation of zolbetuximab is complicated by cumbersome administration times, short drug stability, extended observation time, and difficult tolerability. This report describes our experience in implementing zolbetuximab in clinical practice and provides an extensive drug evaluation.

01 Mar 2026·Cancer diagnosis & prognosis

Expression of CLDN18.2 in Invasive Mucinous Adenocarcinomas of the Lung

Article

Author: Kondo, Tetsuo ; Tahara, Ippei ; Mochizuki, Kunio ; Inoue, Tomohiro ; Kasai, Kazunari

Background/Aim: Invasive mucinous adenocarcinoma (IMA) of the lung is a rare adenocarcinoma subtype with abundant intracytoplasmic mucin and poor response to standard non-small cell lung cancer chemotherapy. Molecularly targeted therapies may be useful in IMA. Zolbetuximab is a chimeric IgG1 monoclonal antibody against Claudin-18.2 (CLDN18.2) that induces cell death in CLDN18.2-positive gastric and gastro-esophageal junction adenocarcinomas. If lung IMAs also highly express CLDN18.2, they may be candidates for zolbetuximab treatment. This study evaluated CLDN18.2 expression in lung IMAs by immunohistochemistry. Materials and Methods: We analyzed surgically resected samples comprising 30 IMAs, 10 non-mucinous adenocarcinomas (NMAs), 10 squamous cell carcinomas (SqCCs), 10 small cell carcinomas (SmCCs), 9 large cell carcinomas (LCCs), and 10 large cell neuroendocrine carcinomas (LCNECs) of the lung. Results: We confirmed CLDN18.2 expression (H-score ≥50 points) in 77% of IMA samples. Its expression was rarely observed in other histological types of lung cancer. Conclusion: CLDN18.2 is frequently expressed in IMAs but rarely in other major lung cancer subtypes, suggesting that zolbetuximab may represent a promising targeted therapy for IMA.

125

News (Medical) associated with Zolbetuximab

27 Apr 2026

·www.fiercepharma.com

Astellas counts on new medicines to offset projected Xtandi decline in fiscal 2026

On a corporate level, drug pricing uncertainty in the U.S. has been a major overhang for Astellas and other mid-sized pharma companies alike. With Xtandi's growth days numbered, an unfazed Astellas expects a group of new products will more than offset the decline of the Pfizer-partnered blockbuster in fiscal year 2026.Xtandi global sales hit 960.8 billion Japanese yen ($6 billion) in Astellas’ fiscal 2025, “reaching projected peak sales levels 13 years after launch,” CEO Naoki Okamura said during an English-dubbed investor call Monday.However, compared with a 5.3% increase in Xtandi sales in fiscal 2025, Astellas expects the prostate cancer drug’s revenue to drop by 5.3% in fiscal 2026, which ends in March 2027. Growth will likely not return for Xtandi. Astellas attributed the projected decline to a price reduction under the Inflation Reduction Act beginning in 2027, the same year that the drug is also slated to lose U.S. market exclusivity. Astellas is bracing for a group-wide revenue decline once the anti-androgen med falls off the patent cliff. But at least for fiscal 2026, the Japanese pharma hopes five strategic brands will deliver 130 billion yen in additional sales—which would represent 27% growth—and will therefore, drive overall company growth by 4% year over year based on unchanged exchange rates.The five products are Pfizer-partnered antibody-drug conjugate Padcev, eye med Izervay, CLDN18.2 cancer drug Vyloy, menopause therapy Veozah and leukemia treatment Xospata. Together, the five brands contributed 480.3 billion yen (around $3 billion) in fiscal 2025 sales, up 43% year over year. Starting from this year, Astellas will not provide sales forecasts for each individual strategic brand.“We believe it is important to grow five strategic brands as one whole, and we hope to engage in dialogue focused on mid- to long-term growth trajectory, rather than being preoccupied with the short-term fluctuations in individual products,” Okamura said. Among the five brands, Padcev is clearly the star. Following a landmark FDA approval as part of a Keytruda combination for the perioperative treatment of cisplatin-ineligible muscle-invasive bladder cancer patients in November, year-on-year U.S. sales growth of the Nectin-4 agent accelerated to roughly 33% in Astellas’ fourth quarter, reaching 38 billion yen ($239 billion), compared with 13% in the three months before.Padcev is on track to expand its perioperative MIBC indication even further to reach cisplatin-eligible patients based on the positive EV-304 trial. With priority review, the FDA is scheduled to make a decision by Aug. 17, 2026. Based on Padcev’s fast growth, as well as strong demand for Vyloy—which saw sales up 133% in Astellas’ fourth quarter—plus continued uptake of Izervay, Jefferies analysts argued in an April 27 note that Astellas’ 130-billion-yen growth projection for the strategic brands may be conservative.However, during Monday’s call, Astellas’ chief commercial and medical affairs officer, Claus Zieler, cautioned that although Padcev’s uptake in MIBC shot up quickly, a plateau is expected about six months into the launch. For ex-U.S., the company expects the first-line metastatic indication will drive growth for the drug. To potentially maximize Padcev’s value, Astellas has started developing the drug for bladder-sparing treatment of MIBC, Okamura said on the call. By Astellas’ estimate, about 30% of MIBC patients are ineligible for or refuse radical cystectomy, which is a necessary step in Padcev’s existing perioperative indication. A single-arm phase 2 trial was initiated in April for patients who elected not to undergo bladder-removal surgery, and a separate registrational phase 3, EV-309, is planned for the first half of fiscal 2026. Bladder-sparing MIBC, plus potential perioperative approval in China, could further boost Padcev’s outlook as these opportunities are not currently baked into Astellas’ peak sales forecast, Okamura said. On a corporate level, drug pricing uncertainty in the U.S. has been a major overhang for Astellas and other mid-sized pharma companies. The Trump administration has signed “most favored nation” deals with all 17 large pharma companies initially targeted by President Donald Trump, offering price reductions and making certain drugs available on the government’s direct-to-consumer portal, Trumprx.gov, in exchange for tariff exemptions and other benefits. “We haven’t received a letter from the U.S. government,” Okamura said on the call, “but we try to open a channel to discuss with the government authorities.”While Astellas cannot currently quantify the potential impact of the policy, the company has examined information from existing deals to evaluate its options, the CEO said.Astellas launched a multi-year cost optimization program, called “sustainable margin transformation,” in 2024. Through organizational restructuring, streamlining certain infrastructure and reducing investments in mature products, Astellas saved about 11 billion yen in selling, general and administrative expenses during fiscal 2025. Through ongoing cost-reduction efforts, Astellas expects SG&A expenses to decrease by 7% to 800 billion yen in fiscal 2026.

Phase 3Drug ApprovalPhase 2Priority Review

27 Mar 2026

·allsci.com

Astellas terminates first-in-human study of STING inhibitor in Sjögren’s syndrome

Astellas Pharma (Japan) has terminated its Phase I clinical trial of ASP5502, an oral small-molecule STING (Stimulator of Interferon Genes) inhibitor, in healthy adults and patients with primary Sjögren’s syndrome. The clinical trial terminated before completion, according to an updated record on ClinicalTrials.gov (NCT06544642), with the status verified as of March 2026. The study, which began enrolling participants in August 2024 at a Fortrea Clinical Research Unit in Daytona Beach, Florida, had been designed as a first-in-human evaluation of the compound. No results have been posted to the registry. The study was a randomized, double-masked, placebo-controlled Phase I trial with a three-part design: single ascending doses (including a food-effect cohort), multiple ascending doses in healthy volunteers over 14 days, and a 28-day repeated-dose cohort in adults with primary Sjögren’s syndrome without a placebo comparator. The trial planned to enroll 116 participants aged 18–65, with primary endpoints focused on safety and tolerability (adverse events, laboratory abnormalities, vital signs, and ECGs) and secondary endpoints assessing pharmacokinetics and cardiac safety. The Sjögren’s cohort required a diagnosis based on 2016 ACR-EULAR criteria and excluded patients receiving immunosuppressive or B-cell–targeting therapies or with other systemic autoimmune conditions. Termination context The study was terminated for strategic reasons, according to the ClinicalTrials.gov NCT06544642 entry, with no indication of safety concerns or lack of efficacy. The decision comes amid Astellas’ broader efforts to prioritize late-stage and core therapeutic areas, although the company has not publicly linked those changes to ASP5502 specifically. ASP5502 was positioned within Astellas’s immune homeostasis research area, which sits outside the company’s four declared primary focus areas: immuno-oncology, targeted protein degradation, genetic regulation, and blindness and regeneration. Astellas has been executing a systematic drug development pipeline update over the past two years, driven in large part by the approaching patent cliff for enzalutamide (Xtandi), its largest revenue-generating product, with generic competition expected around 2027. The company has concentrated resources on late-stage oncology assets — enfortumab vedotin (Padcev), zolbetuximab (Vyloy), and several degrader and antibody-drug conjugate programs — while pruning early-stage assets in non-core therapeutic areas. Prior discontinuations include a CAR-T program derived from the Xyphos acquisition and a KRAS G12D pancreatic cancer program (ASP4396), with the company recording approximately JPY 12.8 billion in discontinuation-related losses. A February 2025 management restructuring created a new Chief R&D Officer role consolidating oversight of research and development divisions, a move interpreted as tightening portfolio governance. AllSci lists no other active clinical trials for ASP5502, although Astellas has not confirmed the molecule’s discontinuation publicly. The Sjögren’s syndrome landscape Primary Sjögren’s syndrome affects an estimated 0.5% to 1.0% of the adult population, predominantly women, and is characterized by lymphocytic infiltration of exocrine glands leading to sicca symptoms — dry eyes and dry mouth — along with systemic manifestations including fatigue, arthralgia, and organ involvement. Despite its prevalence and burden, no therapy has received FDA approval specifically for the treatment of primary Sjögren’s syndrome. Current management relies on symptomatic relief and off-label use of immunosuppressants. The therapeutic landscape has seen repeated clinical failures. Bristol Myers Squibb’s abatacept did not meet its primary endpoint in a Phase III trial. Novartis tested ianalumab (an anti-BAFF receptor antibody) and reported mixed results, though development continues. GSK’s belimumab, approved for lupus, has been explored in Sjögren’s syndrome without regulatory success in that indication. Horizon Therapeutics (now Amgen) evaluated teprotumumab but in a different autoimmune context. The BAFF/APRIL axis, B-cell depletion, and T-cell co-stimulation blockade have all been pursued with limited translational success in this disease. STING inhibition represented a mechanistically distinct approach. The STING pathway, part of the innate immune system’s cytosolic DNA sensing machinery, has been implicated in the pathogenesis of several autoimmune conditions, including Sjögren’s syndrome, where aberrant type I interferon signaling is a recognized feature. Preclinical rationale for targeting STING in Sjögren’s syndrome rests on the observation that chronic activation of the interferon pathway contributes to glandular inflammation and tissue damage. However, translating STING pathway modulation into clinical benefit in autoimmune disease remains unproven, and ASP5502 was among the first oral STING inhibitors to enter human testing for this indication. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 1Phase 3ImmunotherapyClinical Result

10 Mar 2026

·endpoints.news

BioNTech co-founders to exit company and start a new one

Uğur Şahin and Özlem Türeci are set to leave BioNTech by the end of the year and establish a new company dedicated to next-generation mRNA innovations. BioNTech itself will narrow its focus to its late-stage pipeline, and the hunt is on to find a new leadership team. BioNTech said Tuesday that it would contribute certain rights and mRNA technologies to the new, as-yet-unnamed company “on an arm’s length basis” in exchange for a minority stake and possible milestones and royalties. A binding agreement is set to be signed by the end of June. Exactly what this new biotech will work on is not wholly clear, with the announcement simply saying “next-generation mRNA innovations with disruptive potential.” “Özlem and I are ready to become pioneers once again,” Şahin said in a statement. “Our vision has always been to translate our science into meaningful advances for patients, and we see extraordinary opportunities to unlock the next generation of transformative innovations.” Aside from the part-ownership by BioNTech, the new entity will have distinct resources, operations and funding options. The idea is that the two companies’ different strategic priorities — one focused on discovery and early development of new tech, the other on late-stage development and commercialization — will create more value for shareholders. Helmut Jeggle, chairman of BioNTech’s supervisory board, said the two companies might work together on potential combination therapies. Şahin, BioNTech’s CEO, and Türeci, the company’s chief medical officer, founded the company in 2008 with Christoph Huber, initially focusing on cancer. It hit the big time when the biotech used its mRNA expertise to develop a highly effective — and highly lucrative — shot for Covid-19, in collaboration with Pfizer. In recent years, BioNTech has worked hard to diversify away from the Covid vaccine, which remains its only marketed product. Its revenue from the vaccine fell from a peak of nearly €19 billion (about $21 billion) in 2021 to €2.8 billion in 2024, as the pandemic eased. BioNTech’s 2025 revenue came in at €2.9 billion, BioNTech said in a separate release Tuesday. The company’s net loss was €1.1 billion, up from €665 million the year prior. Its sales guidance for 2026 is between €2 billion and €2.3 billion. BioNTech’s late-stage pipeline is cancer-focused. It includes gotistobart, an anti-CTLA-4 antibody for lung cancer; pumitamig, a bispecific in the hot space of targeting PD-L1 and VEGF-A, in Phase 3 development for lung and breast cancers; and the HER2-targeting antibody-drug conjugate trastuzumab pamirtecan, for breast and endometrial cancer. The latter could become BioNTech’s next approved product, though not in the US. Following a successful China-based trial conducted by BioNTech’s partner DualityBio, a Chinese BLA filing is being planned. BioNTech said that its pipeline will be unaffected by the plans for the new company, adding that it expects to have 15 ongoing Phase 3 cancer trials by the end of 2026, eight of which will be for pumitamig, in collaboration with Bristol Myers Squibb. BioNTech also has six late-stage data readouts that “will inform regulatory and launch plans” across various cancers on this year’s slate. Soon after that, Şahin and Türeci will be at their new company, their third startup. In 2001, they founded Ganymed Pharmaceuticals, and 15 years later, sold it to Astellas for $1.4 billion. The centerpiece of that deal was a Claudin18.2-targeted antibody, which was approved in the US as Vyloy last year. The Tuesday announcement adds to a long string of departures so far this year that includes CEOs from Bavarian Nordic , Sarepta , Sanofi , Alkermes , CSL and Charles River . Editor’s note: This article was updated to include BioNTech’s 2025 financial results.

VaccineAcquisitionmRNAFinancial StatementPhase 3

100 Deals associated with Zolbetuximab

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Zolbetuximab	-	DB15118

R&D Status

Approved

10 top approved records.

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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.

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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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06901531 (LUCERNA, ASCO_GI2026)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| PD-L1 positive Solid Tumors \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2-positive \| HER2-negative \| PD-L1-positive	500	Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6	vfjsyiyvcu(mbftcslkgw) = ltxnfuyikx elvtzvjifd (cyprddgorq, 24.9 - NR)	Positive	08 Jan 2026
				Placebo + pembrolizumab + CAPOX/mFOLFOX6	nfdfcrnoco(rthnjaqsnz) = tvsmxovjzf nleewvnril (sdjkjwkfpi, 43.1 - 56.9) View more
ESMO_ASIA2025	Not Applicable	Advanced gastric carcinoma	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	evtvmztexi(dsmprcikzc) = zlaliyvczn gtmdsffrhv (rongjktmuv ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Advanced Gastroesophageal Junction Adenocarcinoma First line	22	Zolbetuximab (Zolb) + chemo	dhyndugest(mgmepmnduh) = abdominal pain (18%) oqvpaqsuvf (daolpszqno ) View more	Positive	05 Dec 2025
NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	jjvphmxihk(oakjhppbxk) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). xtzszbytod (ruwdgeyaxt ) View more	Positive	05 Dec 2025
				Placebo plus mFOLFOX6/CAPOX
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	Phase 3	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	mgdqssraeq(kufaefgdqz) = bwvuhhndwp zghgpjtcxe (qzgemzzjqw, iqggweoodx - mnxhchvnzd) View more	-	26 Feb 2025
NCT03653507 (GLOW, CTgov)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	rslqysgehn(ifxnqydxku) = wzzmpmjyob ehfeuemsjd (anbiecfhnm, gjduzjmtdd - cfptckyuqa) View more	-	27 Jan 2025
				Placebo (CAPOX+ Placebo)	rslqysgehn(ifxnqydxku) = bqbyurulwi ehfeuemsjd (anbiecfhnm, rzihzyybkg - cjnramwqnb) 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	kuigplqtrn(wybiwgdynb) = qxhosbdfxn qhkunxaixu (rpwvdknxqb, 6.7 - 16.7) View more	Positive	28 Sep 2024
				安慰剂+mFOLFOX6	kuigplqtrn(wybiwgdynb) = erucfublnb qhkunxaixu (rpwvdknxqb, 6.0 - 8.4) 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	jgxszufxpa(urfykelezm) = vkycualiec qwdfjlphhj (sztudvrnqm, 6.1 - 9.1) View more	Positive	28 Sep 2024
				安慰剂联合CAPOX	jgxszufxpa(urfykelezm) = nipmhkgkma qwdfjlphhj (sztudvrnqm, 5.0 - 8.0) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	qrqpjiylfu(eddepsuyui) = gtbcaknpri pldtqqtmtx (oijfqcfdmp, 8.4 - 10.4) View more	Positive	16 Sep 2024
				Placebo + chemotherapy	qrqpjiylfu(eddepsuyui) = bugoibuhgu pldtqqtmtx (oijfqcfdmp, 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	recpkprugx(auvqcvtzhh) = bhdckjxgoc dzrulkzhpc (pkqcuqbycf ) View more	Positive	24 May 2024
				Placebo + mFOLFOX6	recpkprugx(auvqcvtzhh) = phsaskoesa dzrulkzhpc (pkqcuqbycf ) View more

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