HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Locally Advanced or Metastatic Pancreatic Cancer With
In brief
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
Key facts
- Study ID
- NCT07296341
- Run by
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- People needed
- 60
- Starts
- 2026-01-08
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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