Evaluating the safety and effectiveness of YH42946 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of YH42946, a novel oral tyrosine kinase inhibitor targeting HER2 and EGFR mutations, in patients with locally advanced or metastatic solid tumors. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to select effective doses for further evaluation. Patients will be monitored for their response to the treatment and any adverse effects.

Why it matters

Who can join: the full rules

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 aberration 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.
  * Adequate Heart function: QTcF≤ 470 ms, LVEF≥ 50%
  * Blood Coagulation: INR or Prothrombin time ≤ 1.5 X ULN, aPTT ≤ 1.5 X ULN

\[Dose Escalation part only\]

* Histologically or cytologically confirmed diagnosis of advanced, and/or metastatic non-hematologic malignancy
* Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)

\[Dose Expansion part only\]

* Patients who have at least 1 measurable lesion
* 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) infection, or active chronic hepatitis B or chronic hepatitis C
* Major surgery within 4 weeks prior to the first dose of study treatment

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• The Catholic Univ. of Korea St. Vincent's Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Chungbuk National University Hospital
  Cheongju-si, North Chungcheong, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Severance Hospital, Yonsei University
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Yuhan Corporation Clinical Operation Team 1
• Email: clinicaltrials@yuhan.co.kr
• Phone: 8228280576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.