The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
HRS-6768
Beijing Gaobo Hospital
Beijing, Beijing Municipality, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPhase 1:Dose-limiting toxicity (DLTs)
To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
Time frame: From first dose of study drug through at least 6 weeks
Phase 1: recommended Phase 2 dose (RP2D)
To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
Time frame: From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)
Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768
Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768
Time frame: From first dose of study drug to end of treatment (up to approximately 2 years)
Phase 2: Progression-free survival (PFS)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions
To measure the radiation dosimetry of HRS-6768
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Cmax of HRS-6768
To evaluate the PK of HRS-6768
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Tmax of HRS-6768
To evaluate the PK of HRS-6768
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
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Phase 1/2: Area under the curve (AUC) of HRS-6768
To evaluate the PK of HRS-6768
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: clearance (CL) of HRS-6768
To evaluate the PK of HRS-6768
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Objective Response Rate (ORR)
Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)
Phase 1/2: Duration of Response (DoR)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1: Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of first dose to the date of first evidence of radiographic progression or death due to any cause, whichever occurred first.
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)