A single arm, open label, multiple ascending dose, prospective, multicentre study to assess safety, tolerability, pharmacokinetics and pharmacodynamic of PNB028 (Test, manufactured by PNB Vesper Life Science Pvt. Ltd., India) in colon or pancreatic cancer patients.

PNB Vesper Life Science Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1. Colon cancer patients who have failed to 2nd line of chemotherapy or pancreatic cancer patients who have failed to 1st line of chemotherapy. Study drug can also be used as 1st line or 2nd line in colon cancer and as 1st line in pancreatic cancer if other lines of treatment are not feasible for any reason.
•2. Eastern Cooperative Oncology Group (ECOG) performance status Less than or equal 2.
•3. Patients with life expectancy of at least 12-24 months in colon cancer and =4 months in pancreatic cancer.
•4. The serum pregnancy test at screening and urine pregnancy test before dosing on day 01 must be negative for female patients of childbearing potential.
•5. Physical examination, 12-lead electrocardiogram (ECG) and vital signs without any clinically significant findings as per discretion of the investigator.
•6.Clinical laboratory values within the acceptable range, unless deemed clinically not significant by the investigator.
•7.Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements as evidenced by signing the Informed Consent Form (ICF).

•1. Patients with known brain metastasis.
•2. Patients with any other malignancy other than colon cancer or pancreatic cancer.
•3.History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic (other than colon and pancreatic cancer), pulmonary, immunologic, musculoskeletal, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
•4.A history of allergic response(s) to cholecystokinin receptor antagonist.
•5.History of chemotherapy or radiotherapy within 2 weeks before screening.
•6.History of biological therapy within 2 weeks before screening.

发起方

PNB Vesper Life Science Private Limited