HS-20117-2 Injection in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHansoh BioMedical R&D Company
About this trial
This trial is a multicenter, open-label, Phase I clinical study designed to evaluate the pharmacokinetics, safety, and tolerability of HS-20117-2 in patients with advanced solid tumors.
Eligibility criteria
Qualifiers
Aged 18 to 75 years, male or female.
According to RECIST v1.1, the investigator assesses that the participant has at least one target lesion.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
Minimum life expectancy greater than 12 weeks.
Disqualifiers
Presence of prior anti-tumor therapy-related toxicities with a severity ≥ Grade 2 (according to CTCAE v5.0), excluding alopecia and neurotoxicity.
Mean QT interval corrected by Fridericia's formula (QTcF) > 470 msec on resting ECG.
Resting ECG abnormalities indicating clinically significant rhythm, conduction, or morphological abnormalities as judged by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval > 250 msec).
Presence of any factor that increases the risk of QT prolongation or arrhythmic events judged by the investigator as clinically significant (e.g., heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval).
Trial design
Treatments tested in this trial
- HS-20117-2 Injection
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov