Ozmosi | Sonesitatug vedotin Drug Profile

Product Description

CMG901 is the first Claudin 18.2 ADC to obtained IND approval in China and in the U.S. CMG901 consists of three components: a monoclonal antibody targeting Claudin 18.2, a cleavable linker and a potent cytotoxic payload (MMAE). Claudin 18.2 has been identified as a highly selective molecule that is widely expressed in multiple solid tumors, including gastric cancer and pancreatic cancer, suggesting that Claudin 18.2 is an ideal target for tumor therapeutic development. (Sourced from: https://en.keymedbio.com/show-132-188-1.html)

Mechanisms of Action: CLDN18.2 Binder

Novel Mechanism: Yes

Modality: Antibody Drug Conjugate

Route of Administration: Intravenous

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Company: AstraZeneca
Company Location: Europe
Company Founding Year: 1999
Additional Commercial Interests: Keymed Biosciences

Clinical Description

Map of Global Clinical Trials for Sonesitatug vedotin

Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, China, France, Georgia, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia, Moldova, Netherlands, Poland, Puerto Rico, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location, Vietnam

Active Clinical Trial Count: 12

Recent & Upcoming Milestones

Clinical Outcomes Reported - AstraZeneca presented P1 Gastrointestinal Cancer results on 2026-05-30 for Sonesitatug vedotin
Clinical Outcomes Reported - AstraZeneca presented P1 Gastrointestinal Cancer results on 2024-06-01 for Sonesitatug vedotin

Highest Development Phases

Phase 3: Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer

Phase 2: Biliary Tract Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma

Phase 1: Oncology Solid Tumor Unspecified

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT06346392	CLARITY Gastric 01	P3	Active, not recruiting	Esophageal Cancer\|Gastrointestinal Cancer	2026-06-15	52%	2026-05-28
NCT06219941	CLARITY-PanTumour01	P2	Recruiting	Gastrointestinal Cancer\|Esophageal Cancer\|Adenocarcinoma\|Biliary Tract Cancer\|Pancreatic Cancer\|Pancreatic Ductal Carcinoma	2026-08-11	12%	2026-02-13	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
2023-508275-37-00	CLARITY-PT01	P2	Recruiting	Esophageal Cancer\|Biliary Tract Cancer\|Pancreatic Ductal Carcinoma\|Adenocarcinoma\|Pancreatic Cancer\|Gastrointestinal Cancer	2027-03-31		2025-05-02	Treatments
jRCT2031230569	jRCT2031230569	P2	Not yet recruiting	Esophageal Cancer\|Gastrointestinal Cancer	2026-12-31
NCT07143604	GAMBIT	P2	Active, not recruiting	Esophageal Cancer\|Gastrointestinal Cancer	2026-09-28	12%	2026-03-18
jRCT2031250781	jRCT2031250781	P3	Recruiting	Gastrointestinal Cancer\|Esophageal Cancer	2031-06-30
NCT07431281	CLARITY-Gastric 02	P3	Recruiting	Adenocarcinoma\|Esophageal Cancer\|Gastrointestinal Cancer	2029-08-16	54%	2026-04-14	Primary Endpoints\|Treatments
jRCT2031240373	jRCT2031240373	P3	Recruiting	Esophageal Cancer\|Gastrointestinal Cancer	2026-12-31
2023-508276-11-00	D9802C00001	P3	Recruiting	Adenocarcinoma\|Esophageal Cancer\|Gastrointestinal Cancer	2026-10-23	52%	2025-05-02	Treatments
NCT04805307	KYM901	P1	Completed	Esophageal Cancer\|Pancreatic Cancer\|Adenocarcinoma\|Gastrointestinal Cancer	2024-04-05	12%	2025-02-13	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Trial Status
CTR20240730	CTR20240730	P3	Active, not recruiting	Esophageal Cancer\|Gastrointestinal Cancer\|Adenocarcinoma	None		2026-05-10	Patient Enrollment\|Start Date\|Treatments\|Trial Status
CTR20202456	CTR20202456	P1	Active, not recruiting	Oncology Solid Tumor Unspecified	None		2025-04-29

Recent News Events

Date	Type	Title
04/02/2026	News Article	IMFINZI® (durvalumab) + IMJUDO® (tremelimumab-actl) improves PFS in early liver cancer
11/26/2025	News Article	IMFINZI® approved in the US as first and only perioperative immunotherapy for patients with early gastric and gastroesophageal cancers
10/17/2025	News Article	IMFINZI® (durvalumab)-based regimen reduced the risk of death by 22% in early gastric cancer vs. chemotherapy alone in MATTERHORN Phase III trial
08/27/2025	News Article	Keymed Biosciences (02162.HK) Reports Strong Interim 2025 Results with Accelerated Commercialization and Robust R&D Momentum

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Sonesitatug vedotin

Alternative Names: Sonesitatug vedotin, AZD-0901, AZD0901, AZD 0901, cmg-901, cmg 901, cmg901 Clinical Status: Active Latest Update: 2026-05-27 Latest Update Note: Clinical Trial Update