HRS-6768
DrugHRS-6768
NCT Number: NCT06925581
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Beijing Gaobo Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS-6768
Time frame: From first dose of study drug through at least 6 weeks
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)
To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
Time frame: From first dose of study drug to end of treatment (up to approximately 2 years)
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 until disease progression or end of treatment (up to approximately 2 years)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
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)
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)
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)
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)
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 1 years)
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 2 years)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
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)
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)
Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.
Contact information is provided by the study sponsor or research team.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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