A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.
YH32364 is a new type of immunotherapy called a bispecific antibody that targets both Epidermal Growth Factor Receptor (EGFR) and 4-1BB. EGFR is a gene involved in cancer growth, and many cancer treatments aim to target it. 4-1BB, an immune-modulating protein, plays an important role in boosting T cell activity to combat cancer.
YH32364 is a treatment designed to activate 4-1BB specifically in tumors, aiming to avoid the liver-related side effects seen with previous 4-1BB treatments. It also helps block EGFR signals, assumed to make EGFR-targeted therapies more effective by overcoming resistance.
This study is consists of two parts. In Part 1, participants will be assigned sequentially to one of six dose levels, ranging from the lowest to the highest dose as determined by the sponsor, in order to identify an appropriate dosage.
In Part 2, participants will be randomly assigned to one of the two optimal dose levels identified in Part 1 to confirm the recommended dose.
The YH32364 will be administered via intravenous (IV) infusion once every two weeks. Participants will be required to visit the study site regularly for treatment and assessments. During all the visits, the doctors check participants' health and take note of any unwanted effects.
Inclusion Criteria:
[Dose Escalation Only] Locally advanced or metastatic EGFR overexpressing solid tumor* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy
* One of the following pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+) tumors.
[Dose Expansion Only] Cohort 1: Pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+), locally advanced or metastatic HNSCC other than nasopharyngeal carcinoma (NPC)* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy.
Exclusion Criteria:
Known uncontrolled central nervous system (CNS) metastases, spinal cord compression, and/or carcinomatous meningitis
Have history of a second primary cancer with the exception of
Have history of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA)
Have history of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks
Have history of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis
Have autoimmune disease that has required systemic treatment
Infection with human immunodeficiency virus (HIV)
Active chronic hepatitis B or chronic hepatitis C
[Prior/Concomitant Therapy]
clinicaltrials@yuhan.co.kr+82-2-828-0150
clinicaltrials@yuhan.co.kr+82-2-828-0150