A Study of HS-20197 in Participants With Advanced Solid Tumors
ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females, aged ≥ 18 years.
Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
Disqualifiers
Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.
Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.
Major surgery within 4 weeks prior to the first dose of study treatment.
Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20197
DrugHS-20197 (Phase Ia：Dose escalation ) * HS-20197 for IV infusion of various dose strengths administered in 21 day dosing cycles HS-20197 (Phase Ib:Dose expansion ) * The recommended dose from the dose-escalation stage and other potential doses will be further explored
Treatment groups
595 Participants
are divided into 2 treatment groupsGroup A: Phase Ia：Dose escalationExperimental treatment 1 intervention
Group B: Phase 1b Dose expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
RDE will be determined using DLTs and number of participants with treatment-related adverse events as assessed by CTCAE v6.0 and preliminary clinical efficacy
Time frame
From Day 1 to 21 days after first dose2
Recommended dose for expansion (RDE) of HS-20197 monotherapy
To comprehensively evaluate the safety, pharmacokinetic profile, and preliminary clinical efficacy to determine the recommended dose for expansion (RDE).
Time frame
From Day 1 to 90 days after last doseSecondary outcomes
1
Objective response rate (ORR)
Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1
Time frame
From screening to up to 3 years after last dose2
Disease control rate (DCR)
Defined as the proportion of participants with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1
Time frame
From screening to up to 3 years after last dose3
Duration of response (DoR)
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame
From screening to up to 3 years after last dose4
Progression-free survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first
Time frame
From screening to up to 3 years after last doseSponsors and contacts
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Source ClinicalTrials.gov
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