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NCT02881138

A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors

Completed Phase 1 Last updated 30 July 2020
What this trial tests

Phase 1 trial testing RC48-ADC in Solid Tumors in 24 participants. Completed in 15 July 2020.

Timeline
1 March 2016
Primary endpoint
30 April 2020
15 July 2020

Quick facts

Lead sponsorRemeGen Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment24
Start date1 March 2016
Primary completion30 April 2020
Estimated completion15 July 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

RemeGen Co., Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive

Publications & conference data

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

  1. Breast Cancer Treatments: Updates and New Challenges.
    Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808
  2. HER2 Directed Antibody-Drug-Conjugates beyond T-DM1 in Breast Cancer.
    Rinnerthaler G, Gampenrieder SP, Greil R. · · 2019 · cited 157× · PMID 30841523 · DOI 10.3390/ijms20051115
  3. 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
  4. 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
  5. 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
  6. Clinical perspective: Antibody-drug conjugates for the treatment of HER2-positive breast cancer.
    Najminejad Z, Dehghani F, Mirzaei Y, Mer AH, et al · · 2023 · cited 45× · PMID 36950736 · DOI 10.1016/j.ymthe.2023.03.019
  7. Current and future immunotherapy for breast cancer.
    Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
  8. Actively Targeted Nanomedicines in Breast Cancer: From Pre-Clinal Investigation to Clinic.
    Fraguas-Sánchez AI, Lozza I, Torres-Suárez AI. · · 2022 · cited 37× · PMID 35267507 · DOI 10.3390/cancers14051198

Verify or expand the search:

Other trials of RC48-ADC

Trials testing the same drug.

Other recruiting trials for Solid Tumors

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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