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.
This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors. The study consists of Phase Ia (dose escalation) and Phase Ib (dose expansion). In Phase Ia, dose escalation in monotherapy and combination therapy will conduct to identify the maximum tolerated dose (MTD) in patients with advanced solid tumors. In Phase Ib, potential indications (such as small cell lung cancer or neuroendocrine carcinoma) will be selected for the early proof-of-concept study of HS-20108 at different doses in monotherapy and combination therapy based on the study data from Phase Ia, the translational medicine research data and R\&D progress in the field.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
Intravenous (IV) Infusion
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGMTD or MAD of HS-20108
the maximum tolerated dose or maximum appropriate dose
Time frame: up to approximately 48 months
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 months
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.
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.
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.
Progression-free survival (PFS)
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was defined as the time from date of first dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.
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Time frame: up to approximately 48 months.
overall survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Time frame: up to approximately 48 months.
Observed maximum plasma concentration (Cmax) of HS-20108
Cmax of HS-20108 (administered either as a monotherapy or in combination)
Time frame: up to approximately 48 months.
Area Under the Plasma Concentration-Time Curve (AUC) of HS-20108
AUC of HS-20108 (administered either as a monotherapy or in combination)
Time frame: up to approximately 48 months.
Immunogenicity (administered either as a monotherapy or in combination)
Immunogenicity
Time frame: up to approximately 48 months.