Search / Trial NCT06616766

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

Launched by YUHAN CORPORATION · Sep 26, 2024

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Trial Information

Current as of October 09, 2024

Not yet recruiting

Keywords

Yh42946 101

Description

YH42946 is a novel, orally available tyrosine kinase inhibitor targeting HER2. YH42946 showed potency for diverse HER2 aberrations including HER2 overexpression, amplification, or mutation, as well as EGFR Ex20ins. This is a Phase 1/2, open-label, multicenter, first-in-human study of YH42946. The study has 2 parts. The first part is dose escalation part to identify the maximum tolerated dose. The second part is dose expansion part to select 2 doses for RD selection at the first cohort, after then RD will be determined to ensure its efficacy. Several independent cohorts are planned.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * ECOG performance status 0 or 1
  • * Estimated life expectancy of at least 3 months
  • * Patients who have progressed on or after all available standard therapies or for whom standard treatment is inappropriate
  • * Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 or EGFR mutation
  • * A patient with a history of brain metastases must have had all lesions treated
  • * Adequate organ function defined as all of the following:
  • * Adequate bone marrow function (within 1 week prior to first administration): Neutrophils≥1.5 x10\*9 cells/L (Criteria must be met without the use of Granulocyte-Colony Stimulating Factor (G-CSF) within last week prior to testing.); platelet count≥75 x10\*9 cells/L; Hb ≥9g/dL (Criteria must be met without packed red blood cell (pRBC) transfusion within last week prior to testing.)
  • * Adequate hepatic function: Serum bilirubin≤1.5 x upper limit of normal (ULN), and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases (within 1 week prior to first administration)
  • * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \> 60 mL/min per 1.73 m\*2 according to the site's calculation method.
  • \[Dose Escalation part only\]
  • * Histologically or cytologically confirmed diagnosis of advanced, and/or metastatic non-hematologic malignancy
  • * Documented HER2 or EGFR mutation (HER2 tyrosine kinase domain mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)
  • \[Dose Expansion part only\]
  • * Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)
  • Exclusion Criteria:
  • * Patient with symptomatic or progressive brain metastases
  • * Known or suspected leptomeningeal disease (LMD)
  • * Uncontrolled spinal cord compression
  • * History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks
  • * History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
  • * Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study
  • * Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient
  • * History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis
  • * History of a second primary cancer with the exception of
  • 1. curatively treated non-melanomatous skin cancer,
  • 2. curatively treated cervical or breast carcinoma in situ, or
  • 3. other malignancy with no known active disease present and no treatment administered during the last 2 years
  • * Infection with human immunodeficiency virus (HIV) or active chronic hepatitis B or hepatitis C
  • * Major surgery within 4 weeks prior to the first dose of study treatment

About Yuhan Corporation

Yuhan Corporation is a leading South Korean pharmaceutical company dedicated to the research, development, manufacturing, and marketing of innovative healthcare solutions. Established in 1926, Yuhan has a robust portfolio that includes prescription medications, over-the-counter products, and biologics, with a strong emphasis on oncology, infectious diseases, and central nervous system disorders. The company is committed to advancing medical science through strategic partnerships, cutting-edge research, and clinical trials aimed at bringing novel therapies to market. Yuhan's dedication to quality and excellence positions it as a prominent player in the global pharmaceutical landscape.

Locations

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0