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A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
NCT06616766 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.
Conditions Studied
Interventions
- DRUG YH42946
Study Locations (8)
Other
- Seoul National University Hospital — Seoul
- Severance Hospital, Yonsei University — Seoul
- Samsung Medical Center — Seoul
- Asan Medical Center, University of Ulsan — Seoul
Gyeonggi-do
- Seoul National University Bundang Hospital — Seongnam-si
- The Catholic Univ. of Korea St. Vincent's Hospital — Suwon
Virginia
- Next Oncology Virginia — Fairfax
North Chungcheong
- Chungbuk National University Hospital — Cheongju-si
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2028-07-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06616766
The ClinicalTrials.gov registry entry for NCT06616766 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yuhan Corporation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which YH42946 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06616766 reports 8 study locations spanning 4 distinct geographic areas — top geographies include Other, Gyeonggi-do, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06616766 about?
NCT06616766 is a clinical study titled "A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946". The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.
What is the current status of trial NCT06616766?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 161 participants. The study started on 2024-10-02. Estimated completion is 2028-07-29.
What conditions does trial NCT06616766 study?
This clinical trial studies the following conditions: Solid Tumor, NSCLC (Non-small Cell Lung Cancer). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06616766?
The interventions under investigation include: YH42946 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06616766?
This trial is sponsored by Yuhan Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06616766 being conducted?
This trial has 8 study locations across Virginia, Gyeonggi-do, North Chungcheong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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