A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC) Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Multi-center, Placebo-Controlled Study of the Efficacy and Safety of CEND-1 in Combination With Chemotherapy as First-Line Therapy in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261359
• Other study ID #: CEND1-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2024
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Jianming Xu, M.D
• Phone: 13910866712
• Email: Jianmingxu2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention

Drug:
• CEND-1
CEND-1 will be provided as concentrate for solution to be administered via IV injection.
• Gemcitabine
Gemcitabine will be provided as solution to be administered via IV infusion.
• Nab paclitaxel
Nab-paclitaxel will be provided as solution to be administered via IV infusion.

Locations

Country	Name	City	State
China	Chinese People's Liberation Army (PLA) General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.	Approximately 36 months
Secondary	Overall Survival (OS)	OS is defined as the duration from randomization to the time point when death occurs due to any cause.	Approximately 36 months
Secondary	Progression Free Survival(PFS)	PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).	Approximately 36 months
Secondary	6-month PFS rate	6-month progression-free survival (PFS) rate.	Approximately 36 months
Secondary	Duration Of Response (DOR)	DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).	Approximately 36 months
Secondary	Disease Control Rate (DCR)	DCR was defined as the percentage of confirmed CR, PR or stable disease at the best response as assessed by investigator evaluation per RECIST 1.1.	Approximately 36 months
Secondary	Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs)	Adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events are included. The investigator should carry out judgment for investigational drug correlation.	From the subject signs the ICF to 30 days after the last dose of study drug was administered.