Actively Recruiting
IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2025-04-30
70
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
CONDITIONS
Official Title
IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agreed to participate and signed informed consent
- Female or male subjects aged 18 years or older
- Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)
- No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer
- At least one measurable lesion per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months as assessed by investigator
- Recovered from all adverse events due to previous anticancer therapies to Grade 1 or stable status; alopecia of any grade and Grade 2 peripheral neuropathy allowed
- Adequate bone marrow, liver, renal, and coagulation function
- Female subjects must not be pregnant or breastfeeding and either not be women of childbearing potential or agree to contraceptive guidance
You will not qualify if you...
- Major surgery or major trauma within 28 days prior to first study treatment dose
- Known BRCA1/2 mutations
- Prior systemic anticancer therapy within 28 days before first treatment dose
- Previous treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, other checkpoint inhibitors, or focal adhesion kinase inhibitors
- Radical radiotherapy within 3 months or palliative radiotherapy within 2 weeks prior to first treatment dose
- Prior allogeneic hematopoietic stem cell or organ transplantation
- Live or live attenuated vaccines within 28 days before first treatment dose
- Interstitial pneumonia or lung disease
- History or current active autoimmune diseases
- Prior malignancy except certain cured or in situ cancers within 5 years
- Active central nervous system metastases or carcinomatous meningitis
- Major cardiovascular, cerebrovascular, or thromboembolic disease within 6 months before first treatment dose
- Active infection poorly controlled systemically
- Known HIV infection, active hepatitis B or C, active syphilis or tuberculosis
- Any other condition or abnormality that may interfere with study participation or results, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
B
Bohong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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