Drugs / IBI343
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05458219 | Oct 2022 → Jun 2027 expected | cancer of unknown primary site | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07025889 | Jun 2025 → Jun 2026 overdue | gastric cancer | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07483554 | Apr 2026 → Mar 2028 expected | gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07483567 | Apr 2026 → Jun 2030 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07415525 | Feb 2026 → Dec 2028 expected | adenocarcinoma, malignant pancreatic neoplasm | Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06770439 | Apr 2025 → Jan 2027 expected | pancreatic adenocarcinoma | Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06321913 | Mar 2024 → Dec 2025 | gastroesophageal adenocarcinoma | Harbin Medical University | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07066098 | Jul 2025 → Jun 2027 expected | malignant pancreatic neoplasm | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06238843 | Jun 2024 → Dec 2026 expected | gastroesophageal adenocarcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT07692750 Comparator | Apr 2025 → Jun 2027 expected | malignant exocrine pancreas neoplasm | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-04 | Innovent Biologics (Suzhou) Co. Ltd. | Results World's First CLDN18.2 ADC for Regulatory Review: Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met Primary Endpoint in International Phase 3 Study in Advanced Refractory Gastric Cancer and NDA Accepted by China NMPA innoventbio.com ↗
Arcotatug tavatecan demonstrated excellent efficacy and a tolerable safety profile in the treatment of advanced gastric cancer. |
| 2025-07-17 | Innovent Biologics (Suzhou) Co. Ltd. | Results Nature Medicine Published Phase 1 Results of Innovent Biologics’ Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that Nature Medicine (IF: 58.7) has published the results of the Phase 1 clinical study of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma[Link]. |
| 2025-06-03 | Innovent Biologics (Suzhou) Co. Ltd. | Results ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI343 (Novel Anti-CLDN18.2 ADC) From the Phase 1 Clinical Study in Patients with Advanced Pancreatic Cancer innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, updated the Phase 1 study results of IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2025-01-16 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives NMPA Breakthrough Therapy Designation for IBI343（Anti-CLDN18.2 ADC）as Monotherapy for Advanced Pancreatic Cancer innoventbio.com ↗ |
| 2024-12-09 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Updated Data From Innovative Anti-CLDN18.2 ADC (IBI343) Phase 1 Study in Patients with Advanced Pancreatic Cancer at the ESMO Asia Congress 2024 innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced updated Phase 1 study results of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024. |
| 2024-07-02 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Oral Presentation at the ESMO Gastrointestinal Cancers Congress 2024 on Latest Clinical Data of Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma innoventbio.com ↗
The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2. |
| 2024-06-13 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer innoventbio.com ↗ |
| 2024-06-02 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents at the 2024 ASCO Annual Meeting on Clinical Data of anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Pancreatic Cancer or Biliary Tract Cancer innoventbio.com ↗
As an innovative TOPOi ADC, IBI343 showed a positive clinical signal in subjects with advanced pancreatic cancer and the incidence of grade 3 or above gastrointestinal adverse events is low. |
| 2024-05-07 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives NMPA Breakthrough Therapy Designation for IBI343（Anti-Claudin18.2 ADC）as Monotherapy for Advanced Gastric Cancer innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343 as monotherapy for the treatment of claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least 2 lines of prior systematic treatments. |
| 2024-04-08 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2024 AACR Annual Meeting innoventbio.com ↗
It demonstrated Claudin 18.2-specific in vitro cytotoxicity on a series of cancer cell lines at varying levels of target expression, and potent in vivo efficacy in multiple xeno |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI343 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07483554 ↗ |
| Modality | Monoclonal antibody | “recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate” NCT06770439 ↗ |
| Route | Intravenous | “IBI343 will be administered intravenously (IV) on Day 1 of every 21-day cycle.” NCT05458219 ↗ |