HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
Recruiting · NCT07296341 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabineHRS-4642;nab-paclitaxel; gemcitabine
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).
- At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
Exclusion criteria
- 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)
- Acute or chronic pancreatitis with significant clinical significance
Where it is running
1 location listed.
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China