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Antengene Receives CDE Endorsement to Initiate Pivotal Phase III CLINCH-3 Study of ATG-022 in CLDN18.2+ Advanced Gastric/GEJ Cancer
The trial will test ATG-022 against investigator’s choice after Phase I/II data showed 46.7% and 40.0% response rates, Antengene said.
- On Wednesday, Antengene Corporation Limited received endorsement from China's National Medical Products Administration to conduct the pivotal Phase III CLINCH-3 study of ATG-022, an antibody-drug conjugate targeting advanced gastric or gastroesophageal junction adenocarcinoma.
- Current treatment options for advanced gastric or gastroesophageal junction adenocarcinoma remain limited in the 3L setting, where existing chemotherapy, anti-angiogenic agents and immunotherapy provide insufficient survival benefit and low objective response rates.
- Professor Lin Shen of Peking University Cancer Hospital, principal investigator of CLINCH-3, noted ATG-022 monotherapy at 1.8 mg/kg demonstrated "strong anti-tumor activity, meaningful survival benefit and a favorable safety profile" in earlier trials.
- Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene, called the CDE endorsement a "defining milestone" that underscores the company's integrated R&D capabilities and commitment to advancing the therapy globally.
- The study is expected to initiate in China first as a multi-regional clinical trial , while Antengene simultaneously pursues combination studies with anti-PD-1 therapy and chemotherapy in the 1L gastric cancer setting.
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Antengene Receives CDE Endorsement to Initiate Pivotal Phase III CLINCH-3 Study of ATG-022 in CLDN18.2+ Advanced Gastric/GEJ Cancer
SHANGHAI and HONG KONG, May 27, 2026 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies…
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C 73%
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