sonesitatug vedotin (AZD0901) / Keymed Biosciences, Lepu Med, AstraZeneca - LARVOL DELTA

Antibodies to watch in 2026. (PubMed, MAbs) - "In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab...Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by..."

Journal • Review • Oncology

Claudin 18.2-targeting antibody-drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial. (PubMed, Lancet Oncol) - P1 | "CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer."

Journal • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Pancreatitis • Renal Disease • Solid Tumor • CLDN18

CLARITY-PanTumor01: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Dec 2026 ➔ Sep 2027 | Trial primary completion date: Dec 2025 ➔ Aug 2026

Monotherapy • Pan tumor • Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Sonesitatug vedotin: Data from P3 CLARITY- Gastric 01 trial (NCT06346392) for 2L+ advanced or metastatic gastric or GEJ adenocarcinoma in H1 2026 (AstraZeneca) - FY 2025 Results: Data from P3 CLARITY-PanTumour01 trial (NCT06219941) for locally advanced unresectable or metastatic solid tumors in 2027

P3 data • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

CLARITY-Gastric 01: a randomized Phase 3 study of AZD0901, a Claudin18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC) (DKK 2026) - No abstract available

Clinical • Metastases • P3 data • Gastric Cancer • Oncology • Solid Tumor • CLDN18

A phase 1 trial of claudin 18.2-specific antibody-drug conjugate CMG901 in patients with advanced gastric/gastroesophageal junction cancer (ASCO Plenary Nov 2023) - P1 | "NCT04805307"

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Updates on Abstract 434420: A Phase 1 Trial of Claudin 18.2-Specific Antibody-Drug Conjugate CMG901 in Patients with Advanced Gastric/Gastroesophageal Junction Cancer (ASCO 2024) - No abstract available

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

MODULE 4: Other Novel Agents and Strategies Under Evaluation for Advanced Gastroesophageal Cancers (ASCO-GI 2026) - "This event is organized and accredited by Research To Practice and supported by educational grants from Astellas, BeOne, Gilead Sciences Inc, and Jazz Pharmaceuticals Inc. Potential immunotherapy targets beyond PD-1/PD-L1 and CTLA-4 in gastroesophageal cancers; proposed rationale for targeting TIGIT Updated efficacy findings, including overall survival outcomes, documented with the combination of the anti-TIGIT monoclonal antibody domvanalimab, the anti-PD-1 antibody zimberelimab and chemotherapy as first-line therapy for advanced gastroesophageal adenocarcinoma in arm A1 of the EDGE-Gastric study Emerging outcomes from the Phase III STAR-221 trial comparing domvanalimab/zimberelimab/chemotherapy to nivolumab/chemotherapy for previously untreated advanced gastric, GEJ and esophageal adenocarcinoma Mechanism of action of and early findings with the PD-1/TIGIT bispecific antibody rilvegostomig for advanced gastroesophageal cancers Ongoing Phase III ARTEMIDE-Gastric01 study..."

Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • TIGIT

GEMINI-Perioperative (PeriOp) Gastric: A phase 2 study of novel agent-based combinations as PeriOp therapy for previously untreated, locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma. (ASCO-GI 2026) - P2 | "Background: The standard-of-care treatment for resectable gastric cancer with a high risk of relapse is PeriOp FLOT (5-fluorouracil [5-FU] + leucovorin [isovorin in Japan] + oxaliplatin + docetaxel) and radical surgery. In the MATTERHORN trial, durvalumab + FLOT improved event-free survival versus FLOT alone, establishing a role for immunotherapy + chemotherapy in this setting (Janjigian YY, et al...In substudy 1, CLDN18.2-positive/HER2-negative patients will receive intravenous (IV) sonesitatug vedotin (AZD0901, a CLDN18.2-targeted antibody-drug conjugate) + IV rilvegostomig + 5-FU or capecitabine; in substudy 2, HER2-positive patients will receive IV trastuzumab deruxtecan + IV rilvegostomig + 5-FU or capecitabine; in substudy 3, patients will receive IV rilvegostomig + FLOT...Secondary objectives include the feasibility of surgery, complete resection rate, tumor downstaging, objective response rate, event-free, disease-free, and overall survival, and the..."

Metastases • P2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1 • TIGIT

CLARITY-Gastric 01: A randomized phase 3 study of sonesitatug vedotin (sone ve), a Claudin18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC). (ASCO-GI 2026) - P3 | " Participants (pts) will be randomized 1:1:1 to sone ve dose level 1 intravenous (IV) every three weeks (Q3W; Arm 1), sone ve dose level 2 IV Q3W (Arm 2), or INV choice of therapy (2L: ramucirumab [ram] + paclitaxel [PTX], PTX, or docetaxel [for pts with contraindication to ram only]; 3L+: irinotecan, TAS-102 [excluding China], or apatinib [China only]; Arm 3). Previously presented at European Society for Medical Oncology Gastrointestinal Cancers Congress 2024, Final Publication Number: 495TiP, Kohei Shitara, et al. - Reused with permission."

Clinical • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

CLARITY-Gastric 01: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov) - P3 | N=572 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2027 ➔ Sep 2026 | Trial primary completion date: Oct 2026 ➔ May 2026

Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med) - "Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs."

Journal • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer • CDH17 • CDH6 • CLDN18 • CLDN6

GAMBIT: A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Sep 2026 ➔ Dec 2026

Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

CLARITY-Gastric 01: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov) - P3 | N=572 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Oct 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2026 ➔ Oct 2026

Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

GAMBIT: A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: AstraZeneca

Monotherapy • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

GEMINI-PeriOp GC: A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Sonesitatug vedotin: Data from P3 CLARITY- Gastric 01 trial (NCT06346392) for 2L+ advanced or metastatic gastric or GEJ adenocarcinoma in H1 2026 (AstraZeneca) - H1 and Q2 2025 Results: Data from P3 CLARITY-PanTumour01 trial (NCT06219941) for locally advanced unresectable or metastatic solid tumors post 2026

P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

AZD0901 monotherapy in patients (pts) with advanced biliary tract cancer (BTC) expressing claudin18.2 (CLDN18.2): CLARITY-PanTumour01 substudy 3 (ESMO-GI 2025) - P1, P2 | "Key secondary endpoints are durable response rates at 12 and 24 weeks, progression-free survival, overall survival, pharmacokinetics and immunogenicity. Recruitment began in March 2025 and is underway at sites in Australia, Canada, Georgia, Japan, Korea, Malaysia, Moldova, Poland, Singapore, Spain, Taiwan, and the United States."

Clinical • Metastases • Monotherapy • Pan tumor • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

GEMINI-Gastric: Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jan 2027 ➔ Jul 2027 | Trial primary completion date: Jan 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

VBC108: a first-in-class CDH17/CLDN18.2 targeted bispecific antibody drug conjugate (ADC) to overcome tumor heterogeneity of gastrointestinal cancers (GC, PADC, CRC, etc.) (AACR 2025) - "However, these therapies face challenges due to the heterogeneous expression of CLDN18.2, leading to inconsistent efficacy and the need of patient stratification, as observed with Zolbetuximab, AZD0901 and IBI343. VBC108 also exhibited excellent developability in a comprehensive developability assessment (DA) test, making it a strong candidate for further CMC development. In summary, VBC108, with its unique design, shows the potential as a first-in-class ADC for GI cancer and supports the advancement to clinical trials."

Heterogeneity • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH17 • CLDN18

CLARITY-Gastric 01: a randomized Phase 3 study of AZD0901 in 2L+ advanced gastric/gastroesophageal junction cancers (JSMO 2025) - No abstract available

Clinical • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

KYM901: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901 (clinicaltrials.gov) - P1 | N=176 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Apr 2024

Trial completion • Trial completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

GEMINI-Gastric: Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2026 ➔ Jan 2027 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18