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

NCT06261359 | Recruiting Phase 2

• 1 other identifier: CEND1-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS)

  Approximately 36 months

• Progression Free Survival(PFS)

  Approximately 36 months

• 6-month PFS rate

  Approximately 36 months

• Duration Of Response (DOR)

  Approximately 36 months

• Disease Control Rate (DCR)

  Approximately 36 months

Study Arms (2)

CEND-1+ nab-paclitaxel + gemcitabine

EXPERIMENTAL

Participants will receive nab-paclitaxel 125mg/m2; CEND1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.

Drug: CEND-1; Drug: Gemcitabine; Drug: Nab paclitaxel

Placebo+ nab-paclitaxel + gemcitabine

PLACEBO COMPARATOR

Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.

Drug: Gemcitabine; Drug: Nab paclitaxel

Interventions

CEND-1 DRUG

CEND-1 will be provided as concentrate for solution to be administered via IV injection.

Also known as: iRGD, LSTA1, certepetide

CEND-1+ nab-paclitaxel + gemcitabine

Gemcitabine DRUG

Gemcitabine will be provided as solution to be administered via IV infusion.

Also known as: Gemzar

CEND-1+ nab-paclitaxel + gemcitabine; Placebo+ nab-paclitaxel + gemcitabine

Nab paclitaxel DRUG

Nab-paclitaxel will be provided as solution to be administered via IV infusion.

Also known as: Abraxane

CEND-1+ nab-paclitaxel + gemcitabine; Placebo+ nab-paclitaxel + gemcitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

Gemcitabine; Taxes; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jianming Xu, M.D

CONTACT

13910866712; Jianmingxu2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: March 19, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2023-11

Locations

CN (1)