Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Location contact
Yupei Zhao
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07296341
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Yupei Zhao
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
nab-paclitaxel in combination with gemcitabine
Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months
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: up to 10 months following the date the last patient was randomized
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) 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) 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: From study start until target OS events have occurred (approximately 20 months after last patient enrollment)
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.
Shanghai Hengrui Pharmaceutical Co., Ltd.
Industry
A Phase IB/II Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With 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.