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
Qualifiers
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
Treatments tested in this trial
- HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine
- HRS-4642;nab-paclitaxel; gemcitabine
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov