Actively Recruiting
Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
Led by Fudan University · Updated on 2024-08-09
35
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebelimab in subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma.
CONDITIONS
Official Title
Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily agree to participate and have signed informed consent
- Age between 18 and 75 years, male or female
- Diagnosis of advanced (metastatic or unresectable) pancreatic ductal adenocarcinoma with at least one measurable lesion as per RECIST v1.1
- Failed or have no standard treatment, including progression within 6 months after adjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function
- Adverse events from previous anti-tumor therapy recovered to grade 1 or stable, except hair loss of any grade and peripheral neuropathy grade 2
- Female participants of childbearing potential must have a negative pregnancy test within one week before starting study medication and agree to use effective contraception during the study and for 3 months afterward; male participants with partners of childbearing potential must also agree to use effective contraception during this time
You will not qualify if you...
- Known allergy to the investigational drugs or their components
- Other active cancers within the past 5 years
- Received systemic anti-tumor therapy in the 4 weeks before study start or palliative radiotherapy within 14 days before first dose
- Previous allogeneic hematopoietic stem cell or organ transplant
- Untreated or active central nervous system metastases
- Severe cardiovascular or cerebrovascular thromboembolism within 6 months prior to study entry
- Poorly controlled hypertension (systolic 6 150 mm Hg or diastolic 6 100 mm Hg)
- Late-stage symptoms with risk of life-threatening complications soon
- Interstitial lung disease, non-infectious pneumonia, severe uncontrolled internal diseases, acute infections, or recent major surgery within 28 days or not recovered from surgery effects
- Participation in other drug or device clinical trials within 4 weeks prior to first dose
- Congenital or acquired immune deficiency, active hepatitis B or C infection
- Active autoimmune diseases or history of autoimmune disease
- Systemic corticosteroids or immunosuppressants within 2 weeks before first medication
- High risk of pancreatitis with serum amylase and/or lipase levels 6 3 times upper limit of normal unless simple lipase increase as judged by researchers
- Other conditions deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Si Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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