Drugs / Disitamab Vedotin
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06663007 | Sep 2024 → May 2027 expected | prostate cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06055153 | Sep 2023 → Feb 2025 | esophageal squamous cell carcinoma | Changhai Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04311034 | Sep 2018 → Dec 2021 | non-small cell lung carcinoma | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07584733 | May 2026 → Dec 2027 expected | renal pelvis/ureter urothelial carcinoma | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07474324 | Mar 2026 → Dec 2028 expected | gastroesophageal junction adenocarcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06992362 | May 2025 → Dec 2026 expected | hepatoid adenocarcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06574763 | Sep 2024 → Sep 2025 overdue | ovarian cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06420973 | May 2024 → May 2027 expected | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06385873 | May 2024 → May 2027 expected | gastroesophageal junction adenocarcinoma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06063018 | Aug 2023 → Aug 2025 overdue | cervical cancer | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05957757 | Aug 2023 → Jun 2026 | non-invasive bladder urothelial carcinoma | RenJi Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05912816 | Jun 2023 → Nov 2025 overdue | renal pelvis/ureter urothelial carcinoma | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05241899 | May 2022 → May 2023 | gastric cancer | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT06016062 Background | Sep 2023 → Dec 2025 overdue | cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-06-28 | RemeGen Co., Ltd. | Results The Journal of Clinical Oncology (JCO) Publishes Full Results of Disitamab Vedotin in a "Triple-Drug Combination" (RCTS) Regimen for First-Line Gastric Cancer Therapy remegen.com ↗
Its efficacy data achieved remarkable milestones: an objective response rate (ORR) of 89.5%, a median progression-free survival (PFS) of 13.8 months, and a median overall survival (OS) of 31.9 months. |
| 2026-05-21 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 君实生物宣布特瑞普利单抗一线治疗HER2表达尿路上皮癌成功获批 junshipharma.com ↗
本次新适应症的获批主要基于RC48-C016研究（NCT05302284）的研究数据。 |
| 2026-04-17 | RemeGen Co., Ltd. | Results 2026 EAU | Original Research Findings on Disitamab Vedotin Unveiled: Showcasing Breakthroughs in Urothelial Carcinoma Care remegen.com ↗
In the real-world multicenter study led by Professor Cuijian Zhang from Peking University First Hospital, DV alone or combined with PD-1 inhibitor demonstrated favorable efficacy and manageable safety profile in patients with HER2-expressing HR-NMIBC. |
| 2026-02-28 | RemeGen Co., Ltd. | Results 2026 ASCO-GU | RC48-C017 study update: Disitamab vedotin plus immunotherapy as neoadjuvant treatment delivers lasting survival gains in bladder cancer. remegen.com ↗
The results showed that this combination therapy demonstrated durable disease control and survival benefits during the neoadjuvant phase, with good safety, providing important reference for future clinical practice. |
| 2025-10-20 | RemeGen Co., Ltd. | Results ESMO Congress 2025 Presidential Symposium Oral Presentation | Disitamab Vedotin Achieves Major Breakthrough as First-Line Treatment for Urothelial Carcinoma remegen.com ↗
The results showed that the RC48-C016 study met the dual primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS). |
| 2025-06-03 | RemeGen Co., Ltd. | Results 2025 ASCO ｜ Selected in Rapid Oral Abstract Presentation: Disitamab Vedotin as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer Achieves Efficacy Breakthrough remegen.com ↗
Comparing to the placebo group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement with a potential to extend beneficial population to prior targeted treatment non-response patients. |
| 2025-05-12 | RemeGen Co., Ltd. | Results Poised to Reshape Treatment Landscape: A Phase 3 Clinical Trial on Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS remegen.com ↗
The primary subgroup analysis showed that DV combined with toripalimab significantly improved PFS and OS compared with the standard chemotherapy of la/mUC, irrespective of cisplatin eligibility or HER2 expression level. |
| 2025-05-09 | RemeGen Co., Ltd. | Regulatory RemeGen’s Disitamab Vedotin Gains Approval in China for its Third Indication Making it the First ADC Approved for HER2-Positive Advanced Breast Cancer with Liver Metastasis Globally remegen.com ↗
With the third indication approved in China, disitamab vedotin now is the first ADC clinically available for patients with HER2-positive advanced breast cancer with liver metastasis globally |
| 2025-02-14 | RemeGen Co., Ltd. | Results ASCO GU｜RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer remegen.com ↗
The recently updated data indicated clinically meaningful benefits of this therapeutic approach. |
| 2025-01-28 | Pfizer | Results Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium pfizer.com ↗
Updated efficacy and safety data from an ongoing Phase 2 study (sponsored by Remegen) evaluating the HER2-targeting ADC disitamab vedotin plus toripalimab show encouraging results as a perioperative regimen in HER2-expressing muscle-invasive bladder cancer (MIBC). |
| 2025-01-17 | RemeGen Co., Ltd. | Results JPM 2025 | RemeGen: Maximize Commercial Potential of Pipelines Through Indication Expansion and Therapy Innovation remegen.com ↗
RC118, a CLDN18.2-targeted ADC, has demonstrated a clinically meaningful objective response rate in CLDN18.2-positive gastric cancer patients who have received multiple lines of treatment. |
| 2025-01-07 | RemeGen Co., Ltd. | Results Published in Annals of Oncology: Disitamab Vedotin Combined with PD-1 Inhibitor is a Promising Treatment Option for Locally Advanced or Metastatic Urothelial Carcinoma remegen.com ↗
The nearly-three-year follow-up revealed an objective response rate (ORR) of 73.2% and median overall survival (OS) of 33.1 months, superior to any prospective clinical study on ADC plus PD-1 inhibitor therapy for la/mUC with data published. |
| 2024-12-13 | RemeGen Co., Ltd. | Results 2024 SABCS｜Results Unveiled for the Phase III Study of Disitamab Vedotin in Treating HER2-Positive Advanced Breast Cancer with Liver Metastasis remegen.com ↗
This is the first prospective randomized phase III study globally on a HER2-targeting ADC that demonstrated significant efficacy in patients with HER2-positive advanced BCLM. |
| 2024-10-17 | RemeGen Co., Ltd. | Results IGCS 2024 | Results of Disitamab Vedotin Combined with Cadonilimab for Cervical Cancer First Announced with ORR up to 50% remegen.com ↗
At the meeting, the result of a phase 2 clinical study on Disitamab Vedotin combined with Cadonilimab to treat recurrent or metastatic cervical cancer (AK001) was published for the first time, drawing much attention. |
| 2024-10-15 | RemeGen Co., Ltd. | Regulatory BLA Accepted and Priority Review Granted to Disitamab Vedotin for Its Third Indication of HER2-Positive Advanced Breast Cancer with Liver Metastasis remegen.com ↗ |
| 2024-09-27 | RemeGen Co., Ltd. | Results 2024 CSCO｜Disitamab Vedotin Combined with Camrelizumab and S-1 as Perioperative Therapy for Gastric Cancer Showed Promising Efficacy with a pCR Rate of 30% remegen.com ↗ |
| 2024-09-15 | RemeGen Co., Ltd. | Results 2024 ESMO | Disitamab Vedotin Achieves 33 Months OS as First-Line Treatment of Advanced Urothelial Carcinoma remegen.com ↗
The median overall survival (OS) of this study was 33.1 months, 20 months longer than that (13 months) of the first-line platinum-containing chemotherapy. |
| 2024-06-28 | RemeGen Co., Ltd. | Results The Data of Disitamab Vedotin for Treatment of Breast Cancer Published in Cancer Communications remegen.com ↗
The published article reported the efficacy and safety of Disitamab Vedotin in the treatment of patients with HER2-overexpressing and HER2-low advanced breast cancer (ABC). |
| 2023-11-22 | RemeGen Co., Ltd. | Results JCO, a Top Oncology Journal, Published Research Results of Disitamab Vedotin of RemeGen in the Treatment of Urothelial Cancer remegen.com ↗
Study results showed an objective response rate of 50.5% (95% CI, 40.6-60.3) as assessed by the Blinded Independent Review Committee. |
| 2023-10-13 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物与荣昌生物PD-1与HER2 ADC联合用药临床研究正式获批 gloriabio.com ↗
开展联合用药临床研究的申请正式获得中国国家药品监督管理局（NMPA）批准。 |
| 2023-02-16 | RemeGen Co., Ltd. | Regulatory RemeGen Disitamab Vedotin in Combination with Pyrotinib Maleate Tablets in the Treatment of Non-Small Cell Lung Cancer Approved for Clinical Trials remegen.com ↗ |
| 2022-06-04 | RemeGen Co., Ltd. | Results Disitamab Vedotin appeared on ASCO 2022 meeting and brought exciting clinical data on urothelial carcinoma remegen.com ↗
At ASCO meeting this year, RemeGen announced the results of three clinical studies on Disitamab Vedotin in the form of poster discussion, once again demonstrating its advantages in urothelial carcinoma. |
| 2022-02-18 | RemeGen Co., Ltd. | Results RC48-ADC appeared on ASCO-GU 2022 meeting and the ORR of HER2(3+) patients reached 100% remegen.com ↗
What was particularly surprising was that the objective response rate (ORR) in HER2(3+) patients is as high as 100%. |
| 2021-06-10 | RemeGen Co., Ltd. | Regulatory Disitamab Vedotin has become the first ADC drug created and developed by a China biopharma to receive marketing approval! remegen.com ↗ |
| 2021-06-05 | RemeGen Co., Ltd. | Results RC48-ADC appeared on ASCO 2021 meeting again and brought exciting clinical data remegen.com ↗
This study showed that Disitamab Vedotin has prominent curative effect and survival benefit for patients who has received second-line or above systemic chemotherapy. |
| 2020-09-21 | RemeGen Co., Ltd. | Regulatory RemeGen Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer remegen.com ↗ |
All press releases naming this drug 30 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Disitamab Vedotin | “RC48 (Disitamab Vedotin) is a human epidermal growth factor 2 (HER2)-directed antibody-drug conjugate, with a novel humanized anti-HER2 antibody disitamab conjugated to...” NCT06574763 ↗ |
| Known as | R48-ADC | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095273 ↗ |
| Known as | RC48 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05241899 ↗ |
| Known as | RC48+SOX+Sindilizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06992362 ↗ |
| Modality | Other / unclassified | “The anti-HER2-ADC drug RC48 also achieved significant efficacy in HER2-overexpressed advanced urothelial carcinoma” NCT05957757 ↗ |
| Route | Intravenous | “2.5mg/kg by intravenous infusion” NCT05241899 ↗ |
| Target | ERBB2 | “RC48 [a HER2-targeted antibody-drug conjugate (ADC)]” PMID 41816563 ↗ Feb 2026 |