Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYuhan Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must sign an informed consent form (ICF) prior to any study specific procedures
ECOG performance status 0 or 1
Estimated life expectancy of at least 3 months
A woman must not be breastfeeding
Disqualifiers
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
curatively treated non-melanomatous skin cancer
curatively treated cervical or breast carcinoma in situ, or
Trial design
Design model
Single group
Treatments tested in this trial
YH32364
DrugDose Escalation Part: In this part, 6 dose levels are planned and approximately 30 patients will be enrolled. After each dose level, Safety Review Committee (SRC) will evaluate the available safety, tolerability, PK of YH32364 to decide the next dose. Dose Expansion Part: 50 participants with previously treated locally advanced or metastatic EGFR overexpressing HNSCC other than NPC will be randomized 1:1 ratio to each dose. (Cohort 1: Participants with locally advanced or metastatic EGFR overexpressing HNSCC other than NPC, whose disease progressed after or who are intolerable to all the available standard treatment)
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: YH32364Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-emergent adverse events (TEAEs) including dose limiting toxicities (DLTs)
To assess the safety and tolerability of YH32364 in order to determine maximum tolerated dose (MTD) and select doses for dose optimization
Time frame
Study Day 1 to Study Day 28 (during the DLTs evaluation period)2
Objective Response Rate (ORR)
To assess the ORR of YH32364 at the recommended dose (RD) according to RECIST v1.1 by Investigator assessment
Time frame
through dose expansion part completion, approximately 1.5 yearSecondary outcomes
1
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the pharmacokinetics (PK) of YH32364
Time frame
through study completion, approximately 2.5 year2
AUC from time 0 to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of YH32364
Time frame
through study completion, approximately 2.5 year3
Maximum observed serum concentration (Cmax)
To characterize the pharmacokinetics (PK) of YH32364
Time frame
through study completion, approximately 2.5 year4
Time to reach Cmax (Tmax)
To characterize the pharmacokinetics (PK) of YH32364
Time frame
through study completion, approximately 2.5 yearOther outcomes
1
Immune ORR (iORR)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Time frame
through study completion, approximately 2.5 year2
Immune Duration of Response (iDOR)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Time frame
through study completion, approximately 2.5 year3
Immune PFS (iPFS)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Time frame
through study completion, approximately 2.5 yearSponsors and contacts
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Source ClinicalTrials.gov