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NCT04714190

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

Status unknown Phase 3 Last updated 21 December 2023
What this trial tests

Phase 3 trial testing RC48-ADC in Gastric Cancer in 351 participants. Status unknown.

Timeline
24 March 2021
Primary endpoint
1 December 2024
30 June 2025

Quick facts

Lead sponsorRemeGen Co., Ltd.
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment351
Start date24 March 2021
Primary completion1 December 2024
Estimated completion30 June 2025
Sites52 locations across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of RC48-ADC

Trials testing the same drug.

Other recruiting trials for Gastric Cancer

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

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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