A Study of HS-20122 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females, aged ≥ 18 years.
Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors
Standard treatment is invalid, unavailable or intolerable.
At least 1 target lesion according to RECIST 1.1.
Disqualifiers
Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
History of other primary malignancies.
Inadequate bone marrow reserve or organ dysfunction.
Evidence of cardiovascular risk.
Trial design
Design model
Single group
Treatments tested in this trial
HS-20122
DrugIntravenous (IV) administration of HS-20122 ; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Treatment groups
1,050 Participants
are divided into 1 treatment groupGroup A: HS-20122Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors
Time frame
From time of first dose of HS-20122 to end of DLT period (approximately 21 days)Secondary outcomes
1
Incidence and severity of adverse events (AEs)
Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.
Time frame
From time of Informed Consent to 28 days post last dose of HS-201222
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame
From time of first dose of HS-20122 to end of DLT period (approximately 21 days)3
Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
The Cmax is the maximum observed drug concentration of HS-20122
Time frame
From the date of first dose until 30 days after the final dose4
Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
The Tmax is defined as time to reach maximum observed drug concentration of HS-20122.
Time frame
From the date of first dose until 30 days after the final dose.Sponsors and contacts
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Source ClinicalTrials.gov