RECRUITING

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

Conditions

NSCLC (Non-small Cell Lung Cancer)Solid Tumor YH42946-101

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion

Quick Facts

Study Start:2024-10-02

Study Completion:2028-07-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06616766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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) * Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)	* 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

Inclusion Criteria

Exclusion 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.
* 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)
* Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)

* 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

Contacts and Locations

Study Contact

Yuhan Corporation Clinical Operation Team 1

CONTACT

8228280576

clinicaltrials@yuhan.co.kr

Principal Investigator

Jeongmin Kim

STUDY_DIRECTOR

Yuhan Corporation

Study Locations (Sites)

Next Oncology Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Yuhan Corporation

Jeongmin Kim, STUDY_DIRECTOR, Yuhan Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02

Study Completion Date2028-07-29

Study Record Updates

Study Start Date2024-10-02

Study Completion Date2028-07-29

Terms related to this study

Keywords Provided by Researchers

YH42946-101

Additional Relevant MeSH Terms

NSCLC (Non-small Cell Lung Cancer)
Solid Tumor