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NCT03507166

A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

Completed Phase 2 Last updated 21 August 2019
What this trial tests

Phase 2 trial testing RC48-ADC in Urothelial Carcinoma in 43 participants. Completed in 29 October 2018.

Timeline
28 December 2017
Primary endpoint
29 October 2018
29 October 2018

Quick facts

Lead sponsorRemeGen Co., Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment43
Start date28 December 2017
Primary completion29 October 2018
Estimated completion29 October 2018
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Urothelial Carcinoma or Advanced Cancer. 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 local advanced or metastatic HER2 positive endothelial cancer.

Publications & conference data

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

  1. 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
  2. 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
  3. 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
  4. 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
  5. Emerging strategies for the improvement of chemotherapy in bladder cancer: Current knowledge and future perspectives.
    Liu S, Chen X, Lin T. · · 2022 · cited 56× · PMID 35777908 · DOI 10.1016/j.jare.2021.11.010
  6. Human epidermal growth factor receptor 2 (HER2)-specific chimeric antigen receptor (CAR) for tumor immunotherapy; recent progress.
    Budi HS, Ahmad FN, Achmad H, Ansari MJ, et al · · 2022 · cited 44× · PMID 35093187 · DOI 10.1186/s13287-022-02719-0
  7. Novel development strategies and challenges for anti-Her2 antibody-drug conjugates.
    Zhang X, Huang AC, Chen F, Chen H, et al · · 2022 · cited 24× · PMID 35146330 · DOI 10.1093/abt/tbac001
  8. Assessment of the expression pattern of HER2 and its correlation with HER2-targeting antibody-drug conjugate therapy in urothelial cancer.
    Lei H, Ling Y, Yuan P, Yan X, et al · · 2023 · cited 16× · PMID 39035731 · DOI 10.1016/j.jncc.2023.02.003

Verify or expand the search:

Other trials of RC48-ADC

Trials testing the same drug.

Other recruiting trials for Urothelial Carcinoma

Currently open trials in the same condition.

Other RemeGen Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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