HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
ECOG performance status 0 or 1
Life expectancy of greater than or equal to 12 weeks.
Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
Disqualifiers
Accompanied by untreated or active central nervous system (CNS) tumor metastasis
Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
Subjects known or suspected to have interstitial pneumonia
According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)
Trial design
Design model
Parallel
Treatments tested in this trial
HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine
DrugHRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
HRS-4642;nab-paclitaxel; gemcitabine
Drugnab-paclitaxel in combination with gemcitabine
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabineExperimental treatment 1 intervention
Group B: nab-paclitaxel in combination with gemcitabineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression 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 monthsSecondary outcomes
1
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 randomized2
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 randomized3
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 randomized4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov