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NCT02881138
A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors
Phase 1 trial testing RC48-ADC in Solid Tumors in 24 participants. Completed in 15 July 2020.
30 April 2020
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 March 2016 |
| Primary completion | 30 April 2020 |
| Estimated completion | 15 July 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- RC48-ADC — full drug profile →
Conditions studied
- Solid Tumors — all drugs for Solid Tumors →
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):
-
Breast Cancer Treatments: Updates and New Challenges.
Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02881138
- 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 Solid Tumors
Currently open trials in the same condition.
- NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
- NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02881138 (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: 30 July 2020
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/NCT02881138.
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