This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
nab-paclitaxel in combination with gemcitabine
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGProgression free survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months
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: up to 10 months following the date the last patient was randomized
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: up to 10 months following the date the last patient was randomized
Duration of response (DoR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as assessed by investigator according to RECIST v1.1.
Time frame: up to 10 months following the date the last patient was randomized
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 study start until target OS events have occurred (approximately 20 months after last patient enrollment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.