NCT06616766 is a Phase 1, PHASE2 clinical trial of YH42946 in NSCLC (Non-small Cell Lung Cancer), sponsored by Yuhan Corporation.

Who is sponsoring NCT06616766?

NCT06616766 is sponsored by Yuhan Corporation.

What drugs are being tested in NCT06616766?

Interventions in NCT06616766: YH42946.

What condition does NCT06616766 study?

NCT06616766 studies NSCLC (Non-small Cell Lung Cancer), Solid Tumor.

Is NCT06616766 still recruiting?

NCT06616766 is currently recruiting now. Last updated 4 November 2025.

Last reviewed 2025-11-04 · How we verify

NCT06616766

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

Recruiting now Phase 1, PHASE2 Last updated 4 November 2025

What this trial tests

Phase 1, PHASE2 trial testing YH42946 in NSCLC (Non-small Cell Lung Cancer) in 161 participants. Currently enrolling.

Timeline

2 October 2024

Primary endpoint
15 March 2028

29 July 2028

Quick facts

Lead sponsor	Yuhan Corporation
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	161
Start date	2 October 2024
Primary completion	15 March 2028
Estimated completion	29 July 2028
Sites	8 locations across United States, South Korea

Drugs / interventions tested

YH42946 — full drug profile →

Conditions studied

NSCLC (Non-small Cell Lung Cancer) — all drugs for NSCLC (Non-small Cell Lung Cancer) →
Solid Tumor — all drugs for Solid Tumor →

Sponsor

Yuhan Corporation — full company profile →

Who can join

18 and older, any sex, with NSCLC (Non-small Cell Lung Cancer) or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

HER2 in Non-Small Cell Lung Cancer (NSCLC): Evolution of the Therapeutic Landscape and Emerging Drugs-A Long Way to the Top.
Trillo Aliaga P, Spitaleri G, Attili I, Corvaja C, et al · · 2025 · cited 3× · PMID 40572608 · DOI 10.3390/molecules30122645

Verify or expand the search:

Other recruiting trials for NSCLC (Non-small Cell Lung Cancer)

Currently open trials in the same condition.

NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07354061 — Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) · Phase 1, PHASE2 · recruiting
NCT07122258 — Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1 · NA · recruiting
NCT07441941 — Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup · recruiting
NCT07330050 — WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC · Phase 2 · recruiting

Other Yuhan Corporation trials

Trials by the same sponsor.

NCT07470125 — Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers · Phase 1 · not yet recruiting
NCT07415551 — Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1- · Phase 2 · recruiting
NCT07265167 — Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects · Phase 1 · completed
NCT07111468 — Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis · Phase 3 · completed
NCT06920719 — Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06616766 (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 Yuhan Corporation
Last refreshed: 4 November 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/NCT06616766.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing