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NCT04714190
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
Phase 3 trial testing RC48-ADC in Gastric Cancer in 351 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 351 |
| Start date | 24 March 2021 |
| Primary completion | 1 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 52 locations across China |
Drugs / interventions tested
- RC48-ADC — full drug profile →
- Paclitaxel injection — full drug profile →
- Irinotecan Hydrochloride Injection
- Apatinib Mesylate Tablets — full drug profile →
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
- HER2 Overexpressing Gastric Carcinoma — all drugs for HER2 Overexpressing Gastric Carcinoma →
Sponsor
RemeGen Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Gastric Cancer or HER2 Overexpressing Gastric Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gastric cancer treatment: recent progress and future perspectives.
Guan WL, He Y, Xu RH. · · 2023 · cited 639× · PMID 37245017 · DOI 10.1186/s13045-023-01451-3 -
Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.
Ferraro E, Drago JZ, Modi S. · · 2021 · cited 164× · PMID 34380530 · DOI 10.1186/s13058-021-01459-y -
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427 -
Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study.
Peng Z, Liu T, Wei J, Wang A, et al · · 2021 · cited 142× · PMID 34665942 · DOI 10.1002/cac2.12214 -
HER2-targeted therapies in cancer: a systematic review.
Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1 -
Antibody-Drug Conjugates for the Treatment of HER2-Positive Breast Cancer.
Najjar MK, Manore SG, Regua AT, Lo HW. · · 2022 · cited 65× · PMID 36360302 · DOI 10.3390/genes13112065 -
Novel ADCs and Strategies to Overcome Resistance to Anti-HER2 ADCs.
Díaz-Rodríguez E, Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2021 · cited 65× · PMID 35008318 · DOI 10.3390/cancers14010154 -
Molecular Pathways and Mechanisms of HER2 in Cancer Therapy.
Raghav KPS, Moasser MM. · · 2023 · cited 38× · PMID 36574481 · DOI 10.1158/1078-0432.ccr-22-0283
Verify or expand the search:
- PubMed search for NCT04714190
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RC48-ADC
Trials testing the same drug.
- NCT06074484 — A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer · Phase 2 · unknown
- NCT06178601 — A Study of RC48-ADC Combined With Cadonilimab(AK104)in the Treatment of HER2-expression Locally Advanced or Metastatic U · Phase 2 · unknown
- NCT05514158 — To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 · Phase 1 · unknown
- NCT05302284 — A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma · Phase 3 · recruiting
- NCT05297552 — A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer · Phase 2 · unknown
Other recruiting trials for Gastric Cancer
Currently open trials in the same condition.
- NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
- NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
- NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting
Other RemeGen Co., Ltd. trials
Trials by the same sponsor.
- NCT07537881 — A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT07462143 — A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT07495033 — Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related I · Phase 3 · not yet recruiting
- NCT07416474 — RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Smal · Phase 3 · not yet recruiting
- NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04714190 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RemeGen Co., Ltd.
- Last refreshed: 21 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04714190.
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