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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
HS-20117-2 Injection
DrugParticipants will receive subcutaneous injections of HS-20117-2 Injection
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: HS-20117-2 Injection Q2W Dosing Regimen:Experimental treatment 1 intervention
Group B: HS-20117-2 Injection Q3W Dosing Regimen:Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of PK parameters of HS-20117: Cmax
Maximum concentration
Time frame
Up to Day 1 of Cycle 2（once every two weeks, each cycle is 14 days） or Day 1 of Cycle 3（once every three weeks, each cycle is 21 days）2
Evaluation of PK parameters of HS-20117: Ctrough
Trough concentration
Time frame
Up to Day 1 of Cycle 2（once every two weeks, each cycle is 14 days） or Day 1 of Cycle 3（once every three weeks, each cycle is 21 days）3
Evaluation of PK parameters of HS-20117: AUC0-14day
Area under the plasma concentration-time curve fom time 0 to 14day
Time frame
Up to 14 days（once every two weeks）4
Evaluation of PK parameters of HS-20117: AUC0-21day
Area under the plasma concentration-time curve fom time 0 to 21day
Time frame
Up to 21 days（once every three weeks）Sponsors and contacts
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Source ClinicalTrials.gov