Drugs / TPX4589
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05001516 | Dec 2021 → Jan 2024 | neoplasm | Turning Point Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05994001 | Aug 2023 → May 2026 overdue | biliary tract cancer | Shanghai Zhongshan Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05188664 | May 2022 → Nov 2023 | neoplasm | LaNova Medicines Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT05161390 | Nov 2021 → Jan 2025 | neoplasm | LaNova Medicines Zhejiang Co., Ltd. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07569068 | Apr 2026 → Apr 2028 expected | gastroesophageal adenocarcinoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07108504 | Aug 2025 → Aug 2026 overdue | chemotherapy-induced toxicity, malignant pancreatic neoplasm | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06519591 | Feb 2025 → May 2026 overdue | gastric cancer, peritoneal carcinomatosis | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06587425 | Jul 2024 → Jul 2025 overdue | adenocarcinoma | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05934331 | Jul 2023 → Jul 2026 overdue | digestive system cancer | LaNova Medicines Zhejiang Co., Ltd. | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07385703 | Apr 2026 → Oct 2028 expected | adenocarcinoma | Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06351020 | Jun 2024 → Nov 2026 expected | gastric adenocarcinoma | LaNova Medicines Zhejiang Co., Ltd. | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07556640 Background | Apr 2026 → Apr 2028 expected | gastric cancer, gastroesophageal adenocarcinoma, peritoneal carcinomatosis | Ruijin Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-25 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 加速上市进程！CLDN18.2 ADC LM-302正式纳入优先审评审批程序 cttq.com ↗
5月22日，中国生物制药（1177.HK）核心企业礼新医药自主开发、上海正大天晴申报的CLDN18.2 ADC——注射用维特柯妥拜单抗（LM-302）正式纳入优先审评审批程序，用于至少接受过两种系统治疗的CLDN18.2阳性、局部晚期或转移性胃/胃食管交界处腺癌患者。 |
| 2021-10-15 | LaNova Medicines Limited | Regulatory 礼新LM-302项目取得NMPA IND批件 lanovamedicines.com ↗
2021年10月14日，礼新公司核心产品之一的 LM-302 抗体偶联药物项目正式取得中国NMPA IND批件。 |
| 2021-06-12 | LaNova Medicines Limited | Regulatory 礼新LM-302项目获得美国IND临床批件 lanovamedicines.com ↗
2021年中，公司 LM-302 抗体偶联药物项目取得美国FDA IND批件。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-25 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 加速上市进程！CLDN18.2 ADC LM-302正式纳入优先审评审批程序 cttq.com ↗ |
| 2026-02-09 | LaNova Medicines Limited | LM-302 （CLDN18.2 ADC）III期临床试验完成受试者入组 lanovamedicines.com ↗ |
| 2021-10-15 | LaNova Medicines Limited | 礼新LM-302项目取得NMPA IND批件 lanovamedicines.com ↗ |
| 2021-06-12 | LaNova Medicines Limited | 礼新LM-302项目获得美国IND临床批件 lanovamedicines.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TPX4589 | “LM-302 (TPX4589)” NCT05001516 ↗ |
| Known as | LM-302 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05161390 ↗ |
| Route | Intravenous | “dose of LM-302 intravenous infusion on day 1” NCT05001516 ↗ |
| Target | CLDN18 | “LM-302, an ADC specifically targeting CLDN18.2 and comprising a monoclonal antibody conjugated to MMAE” NCT06587425 ↗ |