A Phase I Study of HS-20108 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
This is a Phase I clinical study of HS-20108. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged more than or equal to (≥) 18 years.
Participants with pathologically confirmed advanced solid tumors.
At least one measurable lesion in accordance with RECIST 1.1
Fresh or archival tumor tissue available for submission.
Disqualifiers
Inadequate bone marrow reserve or serious organ dysfunction.
Uncontrolled pleural effusion or ascites or pericardial effusion.
Known and untreated, or active central nervous system metastases.
Active autoimmune diseases or active infectious disease
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20108 Monotherapy
DrugIntravenous (IV) Infusion
Treatment groups
502 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: HS-20108 IaExperimental treatment 1 intervention
Group B: HS-20108 Ib Cohort1Experimental treatment 1 intervention
Group C: HS-20108 Ib Cohort2Experimental treatment 1 intervention
Group D: HS-20108 Ib Cohort3Experimental treatment 1 intervention
Group E: HS-20108 and Adebrelimab Ia&IbExperimental treatment 1 intervention
Group F: HS-20108 and SHR-7787 Ia &IbExperimental treatment 1 intervention
Group G: HS-20108、Adebrelimab and SHR-7787 Ia &IbExperimental treatment 1 intervention
Group H: HS-20108 and Cisplatin / Carboplatin Ia&IbExperimental treatment 1 intervention
Group I: HS-20108、Adebrelimab and Cisplatin / Carboplatin Ia&IbExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD or MAD of HS-20108
the maximum tolerated dose or maximum appropriate dose
Time frame
up to approximately 48 monthsSecondary outcomes
1
Incidence of adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered an investigational product, which may present with symptoms, signs, disease, or laboratory abnormalities, but do not necessarily have a causality with the investigational product.
Time frame
up to approximately 48 months2
Objective response rate (ORR) assessed by investigator
ORR is defined as the percentage of patients with a CR or PR that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
Time frame
up to approximately 48 months.3
Disease Control Rate (DCR)
Disease control was defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks).
Time frame
up to approximately 48 months.4
Duration of response (DOR)
Duration of response assessed by RECIST 1.1. Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death.
Time frame
up to approximately 48 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov