We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Cend Therapeutics Inc.
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study was to evaluate the preliminary safety, efficacy and PK characteristics of cend-1 in patients with advanced metastatic pancreatic ductal adenocarcinoma (Chinese population).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: CEND-1 Phase 1 Phase 2

Detailed Description:
This study is a multi-center, non-randomized, open-label phase Ib/II clinical study carried out in Chinese patients with advanced metastatic pancreatic ductal adenocarcinoma.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CEND-1
CEND-1+paclitaxel (albumin-bound type)+gemcitabine
 Drug: CEND-1
The dose is specified according to the protocol. CEND-1+paclitaxel (albumin-bound type)+gemcitabine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jianming Xu +86-010-66887329 jfjzyygw@163.com

Locations
Layout table for location information
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100039
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
Cend Therapeutics Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT05052567    
Other Study ID Numbers: CEND1-201
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms