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
Qualifiers
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
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
Treatments tested in this trial
- YH42946
Treatment groups
161 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov