HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged more than or equal to (≥) 18 years.
Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
Agree to provide fresh or archival tumor tissue and blood samples.
Disqualifiers
Subjects with previous or concurrent malignancies
Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
Inadequate bone marrow reserve or organ dysfunction.
Evidence of cardiovascular risk
Trial design
Design model
Sequential
Treatments tested in this trial
HS-20093
DrugIntravenous (IV) infusion of HS-20093 Q3W; Participants will receive continuous treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Treatment groups
220 Participants
are divided into 4 treatment groupsGroup A: Phase IIa: Cohort 1Experimental treatment 1 intervention
Group B: Phase IIa: Cohort 2Experimental treatment 1 intervention
Group C: Phase IIa: Cohort 3Experimental treatment 1 intervention
Group D: Phase IIbExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
Time frame
From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.Secondary outcomes
1
DOR assessed by RECIST 1.1 criteria
DOR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)
Time frame
From the first dose up to PD or death, whichever came first, assessed up to 24 months.2
Disease Control Rate (DCR) assessed by RECIST 1.1 criteria
DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose.
Time frame
From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months.3
PFS assessed by RECIST 1.1 criteria
PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause
Time frame
From the first dose up to PD or death，whichever came first, assessed up to 24 months.4
Overall survival (OS)
OS was defined as the time from the first dose or random assignment (if any) to death from any cause
Time frame
From the first dose up to PD or death，whichever came first, assessed up to 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov