A Study of HS-20124 in Patients with Advanced Solid Tumors
ConditionSolid Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least age of 18 years at screening;
Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
At least one extra-cranial measurable lesion according to RECIST 1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
Disqualifiers
Previous or current treatment with CDH6 targeted therapy
Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124
Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124
Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20124
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20124 (Phase Ia：Dose escalation )
DrugParticipants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
HS-20124 (Phase Ib: Dose expansion)
DrugParticipants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: HS-20124 (Phase Ia：Dose escalation )Experimental treatment 1 intervention
Group B: HS-20124 (Phase Ib: Dose expansion)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) an
To determine the MTD/MAD for further evaluation of IV administration of HS-20124 in subjects with advanced solid tumors
Time frame
3 weeks after initiation of treatment2
Ⅰb (Dose-Expansion Stage): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) and partial response (PR) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]
Time frame
From the first dose up to PD or withdrawal from study, whichever came first.Secondary outcomes
1
Incidence and severity of treatment-emergent adverse events
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Time frame
From the first dose through 30 days post end of treatment2
Observed maximum plasma concentration (Cmax)
Cmax will be obtained following administration of the first dose of HS-20124 during the first cycle
Time frame
At the end of Cycle 1 (each cycle is 21 days)3
Time to reach maximum plasma concentration (Tmax)
Tmax will be obtained following administration of the first dose of HS-20124 during the first cycle
Time frame
At the end of Cycle 1 (each cycle is 21 days)4
Terminal half-life (T1/2)
Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Time frame
At the end of Cycle 1 (each cycle is 21 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov