NCT03809013 is a Phase 2 clinical trial of RC48-ADC in Urothelial Carcinoma, sponsored by RemeGen Co., Ltd..

Who is sponsoring NCT03809013?

NCT03809013 is sponsored by RemeGen Co., Ltd..

What drugs are being tested in NCT03809013?

Interventions in NCT03809013: RC48-ADC.

What condition does NCT03809013 study?

NCT03809013 studies Urothelial Carcinoma.

Is NCT03809013 still recruiting?

NCT03809013 is currently completed. Last updated 27 November 2023.

Last reviewed 2023-11-27 · How we verify

NCT03809013

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

Completed Phase 2 Last updated 27 November 2023

What this trial tests

Phase 2 trial testing RC48-ADC in Urothelial Carcinoma in 64 participants. Completed in 5 June 2023.

Timeline

7 January 2019

Primary endpoint
4 March 2021

5 June 2023

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	64
Start date	7 January 2019
Primary completion	4 March 2021
Estimated completion	5 June 2023
Sites	8 locations across China

Drugs / interventions tested

RC48-ADC — full drug profile →

Conditions studied

Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Urothelial 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 patients with HER2 overexpressing locally advanced or metastatic urothelial cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy.
Shi F, Liu Y, Zhou X, Shen P, et al · · 2022 · cited 153× · PMID 35506447 · DOI 10.1080/10717544.2022.2069883
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 Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials.
Sheng X, Wang L, He Z, Shi Y, et al · · 2024 · cited 122× · PMID 37988648 · DOI 10.1200/jco.22.02912
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
Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449
HER2-directed antibodies, affibodies and nanobodies as drug-delivery vehicles in breast cancer with a specific focus on radioimmunotherapy and radioimmunoimaging.
Altunay B, Morgenroth A, Beheshti M, Vogg A, et al · · 2021 · cited 74× · PMID 33179151 · DOI 10.1007/s00259-020-05094-1
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

Verify or expand the search:

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 Urothelial Carcinoma

Currently open trials in the same condition.

NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07421700 — Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer · Phase 1, PHASE2 · recruiting
NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · 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 NCT03809013 (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: 27 November 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/NCT03809013.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing