CEND-1 Injection (QLC12102) in Patients With Advanced Metastatic Pancreatic Ductal Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05052567|
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : January 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: CEND-1||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b/2 Clinical Study on Safety, Pharmacokinetics, and Preliminary Efficacy of CEND-1 for Injection in Patients With Advanced Metastatic Pancreatic Ductal Adenocarcinoma|
|Actual Study Start Date :||October 21, 2021|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||May 31, 2023|
CEND-1+paclitaxel (albumin-bound type)+gemcitabine
The dose is specified according to the protocol. CEND-1+paclitaxel (albumin-bound type)+gemcitabine
- Safety of CEND-1 mesured by AEs, SAEs and treatment related adverse events. [ Time Frame: 12 month ]Adverse events (AEs), serious adverse events (SAEs), treatment related adverse events are included. The investigator should carry out judgment for investigational drug correlation.
- Preliminary efficacy of CEND-1 mesured by ORR, DOR, DCR, OS, PFS ect. [ Time Frame: 12 month ]Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), progress-free survival (PFS), PFS rate, OS rate etc. are included.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age: 18 to 80 years old, male or female.
- Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma;
- The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.
- The life expectancy is no less than 12 weeks.
- According to the RECIST v1.1 evaluation criteria, the patient has at least one measurable lesion (exclude if there is only a target lesion located at a site previously treated with radiation);
- The patient who is suitable for first-line treatment with a combined regimen of paclitaxel (albumin-bound type) and gemcitabine;
- The patients who have been previously treated with chemotherapy or other drugs for pancreatic carcinoma, or who have been treated with other anti-cancer drugs, including chemotherapy, targeted therapy, immunotherapy, or biologics.
- The patients who are known to be allergic to the investigatinal drug (CEND-1 analogue) or its any excipient;
- The patients with the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention within 6 months before signing the ICF;
- The patients with symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis. However, the patients with symptomatic CNS metastasis before first administration of the investigational drug, who is treated and stable for no less than 4 weeks, and the systematic hormone (any dose) treatment has been stopped for over 2 weeks, can be enrolled;
- The patients with other active malignant tumors within 3 years before signing the ICF. The cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid cancer are excluded.
- The patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis B and C.
- The patients who participated in any other drug clinical trial and administrated the investigational drug within 4 weeks before first dose;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052567
|Contact: Jianming Xuemail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100039|
|Responsible Party:||Qilu Pharmaceutical Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||September 22, 2021 Key Record Dates|
|Last Update Posted:||January 13, 2023|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type