Last reviewed · How we verify
NCT06083662
Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers
Phase 2 trial testing Neratinib Maleate in Metastatic Cancer in 42 participants. Completed in 30 December 2024.
30 November 2023
Quick facts
| Lead sponsor | Korea University Guro Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 15 June 2021 |
| Primary completion | 30 November 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Neratinib Maleate — full drug profile →
Conditions studied
- Metastatic Cancer — all drugs for Metastatic Cancer →
- HER2 Gene Mutation — all drugs for HER2 Gene Mutation →
Sponsor
Korea University Guro Hospital
Who can join
19 and older, any sex, with Metastatic Cancer or HER2 Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial Study drug : neratinib + herzuma (trastuzumab biosimilar)
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tissue-agnostic biomarkers in solid tumors: current approvals and emerging candidates.
Kim J, Kim HS, Nam M, Chae YK. · · 2025 · cited 3× · PMID 40576713 · DOI 10.1007/s10555-025-10274-2 -
Antibody-drug conjugates in breast cancer: current resistance mechanisms and future combination strategies.
Xing P, Yang C, Hu H, Qian T, et al · · 2025 · PMID 40843356 · DOI 10.20517/cdr.2025.26 -
Phase II study evaluating the safety and efficacy of neratinib and trastuzumab biosimilar in patients with HER2 mutated advanced solid tumors: KCSG AL20-17/KM23 trial.
Lee K, Lee KH, Kim DW, Yoon J, et al · · 2025 · PMID 40211931 · DOI 10.1002/cac2.70026
Verify or expand the search:
- PubMed search for NCT06083662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Neratinib Maleate
Trials testing the same drug.
- NCT06126276 — Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors ( · Phase 2 · recruiting
- NCT05564377 — Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The Co · Phase 2 · recruiting
- NCT05372614 — Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Chang · Phase 1 · suspended
Other recruiting trials for Metastatic Cancer
Currently open trials in the same condition.
- NCT06346197 — Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas · Phase 3 · recruiting
- NCT07144085 — Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases. · Phase 1 · recruiting
- NCT06963723 — Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer · NA · recruiting
- NCT06311851 — Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases · Phase 1, PHASE2 · recruiting
- NCT07011862 — COBRA: Cancer, Older Adults, Balance and Resistance Activities · NA · recruiting
Other Korea University Guro Hospital trials
Trials by the same sponsor.
- NCT07009769 — AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy · completed
- NCT06752733 — Cardiac Stunning After Electrical Cardioversion · active not recruiting
- NCT06202690 — SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC · NA · not yet recruiting
- NCT06889259 — Efficacy and Safety of CBT on Tinnitus · NA · completed
- NCT05704621 — Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Mai · Phase 2 · 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 NCT06083662 (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 Korea University Guro Hospital
- Last refreshed: 18 March 2025
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/NCT06083662.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing