A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYuhan Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
YH42946
DrugYH42946
Treatment groups
201 Participants
are divided into 1 treatment groupGroup A: Part 1 and Part 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Emergent Adverse Events(TEAE)s
To assess the safety and tolerability of YH42946
Time frame
Through study completion, during the first 21 days of DLT evaluation period.2
Objective Response Rate (ORR)
Anti-tumor activity according to RECIST v1.1
Time frame
Through dose expansion part completion, approximately 12 monthsSecondary outcomes
1
AUClast
To characterize the pharmacokinetics (PK) of YH42946
Time frame
Through study completion, approximately 12 months2
AUCinf
To characterize the pharmacokinetics (PK) of YH42946
Time frame
Through study completion, approximately 12 months3
Cmax
To characterize the pharmacokinetics (PK) of YH42946
Time frame
Through study completion, approximately 12 months4
Tmax
To characterize the pharmacokinetics (PK) of YH42946
Time frame
Through study completion, approximately 12 monthsOther outcomes
1
Overall survival(OS)
To assess the overall survival of YH42946
Time frame
Through study completion, approximately 3.5 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov