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Trial Title:
A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma
NCT ID:
NCT06261359
Condition:
Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
CEND-1
Description:
CEND-1 will be provided as concentrate for solution to be administered via IV injection.
Arm group label:
CEND-1+ nab-paclitaxel + gemcitabine
Other name:
iRGD
Other name:
LSTA1
Other name:
certepetide
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine will be provided as solution to be administered via IV infusion.
Arm group label:
CEND-1+ nab-paclitaxel + gemcitabine
Arm group label:
Placebo+ nab-paclitaxel + gemcitabine
Other name:
Gemzar
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Nab-paclitaxel will be provided as solution to be administered via IV infusion.
Arm group label:
CEND-1+ nab-paclitaxel + gemcitabine
Arm group label:
Placebo+ nab-paclitaxel + gemcitabine
Other name:
Abraxane
Summary:
The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination
with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as
first-line treatment in patients with Locally Advanced Unresectable or Metastatic
Pancreatic Ductal Adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18~80 years old, male or female;
- Locally advanced unresectable or metastatic PDAC confirmed by histopathology or
cytopathology;
- Patients who have not received prior systemic therapy for locally advanced or
metastatic pancreatic cancer;
- Patients with at least one measurable tumor lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Expected survival time ≥ 12 weeks;
- Patients who have adequate organ function;
- Female subjects who are not pregnant or not breastfeeding. A negative pregnancy test
for females of childbearing potential within 7 days prior to first dosing. Male and
female subjects of childbearing potential must agree to use highly effective method
of contraception during the entire course of the study and within 180 days after the
end of the study.
- Subjects participate voluntarily and sign informed consent.
Exclusion Criteria:
- Concurrent use of other anticancer drugs, including chemotherapy, targeted therapy,
immunotherapy, or biologics;
- The patients who are known to be allergic to the investigatinal drug or its any
excipient;
- 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;
- Patients with high risk for gastrointestinal bleeding or abdominal bleeding as
assessed by the investigator, such as tumor invasion of the gastro duodenum finger
intestines, large blood vessels, etc.;
- Patients with symptomatic CNS metastasis, leptomeningeal metastasis, or spinal cord
compression due to metastasis.
- Patients with other active malignant tumors within 3 years before signing the ICF.
Patients with cured skin basal cell carcinoma or squamous cell carcinoma, carcinoma
in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid
cancer can be enrolled.
- Patients with human immunodeficiency virus (HIV) infection or known acquired
immunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis B
and C.
- Patients who require systemic antibiotics for ≥7 days within 4 weeks prior to first
dose, or unexplained fever >38.5°C prior during screening or before first dose;
- Patients who participated in any other clinical studies;
- Patients with a known history of psychoactive drug abuse, alcohol abuse, or
substance abuse; History of definitive neurological or mental disorder, including
epilepsy or dementia;
- The patients with added risks associated with the study or may interfere with the
interpretation of study results as determined by the investigator, or deemed
unsuitable by the investigator and/or sponsor.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese People's Liberation Army (PLA) General Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Jianming, M.D
Phone:
13910866712
Email:
Jianmingxu2014@163.com
Start date:
March 19, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06261359
