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.
This is an open-label, multi-center phase 2 study in Chinese adult participants with recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and immunogenicity of HS-20093. This study will consist of two parts: phase IIa and phase IIb. Part 1 (phase IIa) will conducted in participants with relapsed, locally advanced or metastatic esophageal carcinoma and other advanced solid tumor. Subjects will receive one dose levels of HS-20093 intravenously every 3 weeks. Part 2 (phase IIb) will enroll participants with relapsed, locally advanced or metastatic esophageal squamous cell carcinoma. One dose levels of HS-20093 will be administered as an intravenous (IV) infusion every 3 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Intravenous (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.
Anhui Provincial Cancer Hospital
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.
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.
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.
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.
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.
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Hefei, Anhui, China
Fujian Provincial Tumor Hospital
Fujian, Fujian, China
NOT_YET_RECRUITINGThe 900th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Fuzhou, Fujian, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGTumour Hospital of Anyang city
Anyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
RECRUITINGNanyang Central Hospital
Nanyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITING...and 11 more locations
Incidence and severity of 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 until 90 days after the last dose
Characterize the pharmacokinetic parameters of HS-20093
Characterize the pharmacokinetic parameters of HS-20093
Time frame: Cycle 1 Day 1 up to 90 days after the last dose
Assess the incidence of anti-drug antibodies (ADAs)
Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points
Time frame: Cycle 1 Day 1 up to 90 days after the last dose