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

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 | "Funded by AstraZeneca Clinical Trial Registration Number: NCT06346392 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

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

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

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). (ASCO-GI 2025) - P3 | " Participants (pts) will be randomized 1:1:1 to AZD0901 dose level 1 intravenous (IV) every three weeks (Q3W; Arm 1), AZD0901 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-PanTumor01: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov) - P2 | N=190 | Recruiting | Sponsor: AstraZeneca | N=123 ➔ 190 | Trial primary completion date: May 2025 ➔ Dec 2025

Enrollment change • Monotherapy • Trial primary completion date • Biliary Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

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

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 (Lancet Oncol) - P1 | N=162 | NCT04805307 | Sponsor: Keymed Biosciences Co.Ltd | "At median follow-up of 9·0 months (IQR 4·4–12·9), among 113 patients with gastric or gastro-oesophageal junction cancer in the 2·2–3·0 mg/kg cohort full analysis set across both the dose-escalation and dose-expansion phases, the confirmed objective response rate was 28% (95% CI 20–38; 32 of 113 patients). In the 109 patients included in the efficacy analysis set, the confirmed objective response rate was 29% (95% CI 21–39; 32 of 109 patients). Based on overall safety, activity, and pharmacokinetics of CMG901, 2·2 mg/kg was the proposed recommended phase 2 dose."

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

CLARITY-Gastric 01: a randomized Phase 3 study of AZD0901, a Claudin18.2 (CLDN18.2)-targeted antibody drug conjugate, in second- or (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC) (KINGCA Week 2024) - No abstract available

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

Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review). (PubMed, Int J Mol Med) - "The human/humanized anti‑CLDN18.2 mAb osemitamab, and ADCs AZD0901, IBI343 and LM‑302, with single‑agent ORRs of 28‑60%, have been tested in phase III clinical trials. In addition, bsAbs, CAR T cells and their derivatives targeting CLDN4, 6 or 18.2 are in phase I and/or II clinical trials. AZD0901, IBI343, zolbetuximab and the anti‑CLDN1 mAb ALE.C04 have been granted fast track designation or priority review designation by the US Food and Drug Administration."

Journal • Review • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • CLDN1 • CLDN18 • CLDN4 • CLDN6

CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors. (PubMed, Cell Rep Med) - P3 | "CMG901's favorable preclinical profile supports its entry into the human clinical study. CMG901 is currently under phase 3 investigation in patients with advanced gastric/gastroesophageal junction adenocarcinoma expressing Claudin18.2 (NCT06346392)."

Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Keymed Biosciences Announces Interim Results for First Half of 2024 (PRNewswire) - "As of the date of this announcement...an international multi-center Phase III study comparing CMG901...monotherapy versus investigator's choice as second-line or later-line treatment in patients with advanced or metastatic gastric and gastroesophageal junction (G/GEJ) cancer expressing Claudin 18.2 was publicly announced on the drug clinical trial registration and information publicity platform in March 2024. The first patient has received the initial dose in April 2024....Continuously proceeded with a Phase I/II clinical trial in the first half of 2024 to assess the safety, tolerability, pharmacokinetics, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin's lymphoma (NHL). As of the date of this announcement, dose escalation of the intravenous infusion formulation (IV) was completed and the subcutaneous formulation (SC) is in the process of patient evaluation."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

CLARITY-Gastric 01: A randomised phase III 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) (ESMO-GI 2024) - P3 | "CLARITY-Gastric 01 (NCT06346392) is a randomised, open-label, sponsor-blinded, global phase 3 study that will assess the efficacy and safety of AZD0901 vs investigator's (INV) choice of therapy after ≥1 prior therapy for advanced GC/GEJC expressing CLDN18.2.Trial design: Participants (pts) will be randomised to AZD0901 dose level 1 intravenous (IV) every three weeks (Q3W), AZD0901 dose level 2 IV Q3W 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]). Dual primary endpoints are progression-free survival (PFS; intent-to-treat [ITT] pts) and OS (3L+ pts). The secondary endpoints include OS (ITT pts), PFS (3L+ pts), objective response rate and duration of response (ITT and 3L+ pts), and safety/tolerability."

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