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About
To learn if the study drug, YL-13027, is safe to give in combination with gemcitabine and nab-paclitaxel to participants with pancreatic cancer.
Full description
Primary Objectives
Secondary Objectives
Exploratory Objectives
Enrollment
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Volunteers
Inclusion criteria
Age ≥18 years.
Ability to understand and the willingness to sign a written informed consent document. 3. Ability to comply with the study protocol, in the investigator's judgment.
Participants with histologically confirmed metastatic pancreatic adenocarcinoma.
Refractory to one prior line of therapy in the metastatic setting. Participants are also eligible if they finished adjuvant/neoadjuvant therapy in the last 6 months and had disease recurrence.
Measurable disease with at least one lesion amenable to response assessment per the RECIST v1.1 (Appendix 2).
Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix 3).
Adequate organ and marrow function as defined below :
Hemoglobin ≥8.0 g/dL o Absolute neutrophil count ≥1500/mm3
Platelets ≥100,000/mm3
Total bilirubin ≤1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN
AST/ALT ≤2.5 × institutional ULN or ≤5 × ULN for patients with liver metastases
Measured or calculated creatinine clearance (CrCl; Cockcroft-Gault) ≥50 mL/min/1.73 m2. NOTE: For participants determined to be overweight or obese, actual body weight will be used to estimate CrCl.
For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen for at least 2 weeks before study entry.
Albumin ≥ 3 g/dL. 9. Participants must have adequate washout from prior therapy at the time of study treatment initiation: ≥4 weeks from major surgery (excluding biopsy; NOTE: If a participant received major surgery, she/he must have recovered adequately from the toxicity and/or complications from the intervention prior to study treatment initiation); and ≥2 weeks or 5 half-lives (whichever is shorter) from prior therapy.
Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the screening visit until 6 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Refer to Appendix 4 for contraception guidance.
Male participants of childbearing potential must agree to use a highly effective method of contraception and refrain from donating sperm from the screening visit until 3 months after the last dose of study treatment. Refer to Appendix 4 for contraception guidance.
WOCBP must have a negative serum pregnancy test result within 72 hours prior to study treatment initiation.
Participants with secondary malignancies are eligible if the malignancy does not have the potential to interfere with the safety or efficacy assessment of the study treatment. In addition, participants receiving hormonal therapy are eligible if the hormonal therapy does not interfere with the study treatment.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups
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Central trial contact
Jordi Rodon Ahnert, MD
Data sourced from clinicaltrials.gov
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