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Solid Tumor / YH42946 / NSCLC (non Small Cell Lung Cancer) · Phase 1/2 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1/2 first-in-human study evaluating the novel agent YH42946 in patients with HER2-aberrant or EGFR exon 20 insertion-positive solid tumors. No efficacy or safety results are yet reported; the trial is currently recruiting. The study will assess treatment-emergent adverse events during a 21-day dose-limiting toxicity period and objective response rate through approximately 12 months of follow-up.
Phase 1/2, Interventional, Sequential, Open label, Treatment purpose. NSCLC (Non-small Cell Lung Cancer), Solid Tumor; age from 18 Years. Intervention: Part 1 and Part 2. n = 201. 8 sites: United States, South Korea.
This is a planned Phase 1/2 first-in-human study evaluating the novel agent YH42946 in patients with HER2-aberrant or EGFR exon 20 insertion-positive solid tumors. No efficacy or safety results are yet reported; the trial is currently recruiting. The study will assess treatment-emergent adverse events during a 21-day dose-limiting toxicity period and objective response rate through approximately 12 months of follow-up.
Preliminary nature of Phase 1/2 FIH work: dose-limiting toxicity, pharmacokinetics, and preliminary ORR data will be exploratory.
This trial is too early to guide clinical practice. Clinicians should monitor for results from this FIH study, which will provide the first human safety and activity data for YH42946 in the target population.
First-in-human Phase 1/2 open-label trial with planned enrollment of 201 participants; no results yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This trial is too early to guide clinical practice. Clinicians should monitor for results from this FIH study, which will provide the first human safety and activity data for YH42946 in the target population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06616766). This is a study registration, not published results. Lead sponsor: Yuhan Corporation. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 201 participants (ESTIMATED). Conditions: NSCLC (Non-small Cell Lung Cancer), Solid Tumor. Interventions: DRUG: YH42946. Primary outcome measures: Treatment Emergent Adverse Events(TEAE)s , Through study completion, during the first 21 days of DLT evaluation period.; Objective Response Rate (ORR) , Through dose expansion part completion, approximately 12 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.