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NCT03556345
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
Completed
Phase 2
Last updated 13 January 2022
What this trial tests
Phase 2 trial testing RC48-ADC in Gastric Cancer in 127 participants. Completed in 31 August 2020.
Timeline
10 July 2018
Primary endpoint
1 June 2020
1 June 2020
31 August 2020
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 127 |
| Start date | 10 July 2018 |
| Primary completion | 1 June 2020 |
| Estimated completion | 31 August 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- RC48-ADC — 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
Adults 18 to 70, any sex, with Gastric Cancer or HER2 Overexpressing Gastric Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibodies to watch in 2022.
Kaplon H, Chenoweth A, Crescioli S, Reichert JM. · · 2022 · cited 245× · PMID 35030985 · DOI 10.1080/19420862.2021.2014296 -
Signaling pathways and therapeutic interventions in gastric cancer.
Lei ZN, Teng QX, Tian Q, Chen W, et al · · 2022 · cited 220× · PMID 36209270 · DOI 10.1038/s41392-022-01190-w -
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476 -
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 -
Phase I study of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors.
Xu Y, Wang Y, Gong J, Zhang X, et al · · 2021 · cited 116× · PMID 33945049 · DOI 10.1007/s10120-021-01168-7 -
A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers.
Liu K, Li M, Li Y, Li Y, et al · · 2024 · cited 114× · PMID 38519953 · DOI 10.1186/s12943-024-01963-7
Verify or expand the search:
- PubMed search for NCT03556345
- 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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03556345 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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: 13 January 2022
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/NCT03556345.
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