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

Phase 2

Not yet recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Interventions: Drug: CEND-1; Drug: Gemcitabine; Drug: Nab paclitaxel

• Registration Number: NCT06261359
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2025-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEND-1+ nab-paclitaxel + gemcitabine	CEND-1	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.
CEND-1+ nab-paclitaxel + gemcitabine	Nab paclitaxel	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.
Placebo+ nab-paclitaxel + gemcitabine	Nab paclitaxel	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.
CEND-1+ nab-paclitaxel + gemcitabine	Gemcitabine	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.
Placebo+ nab-paclitaxel + gemcitabine	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Approximately 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Approximately 36 months	OS is defined as the duration from randomization to the time point when death occurs due to any cause.
Progression Free Survival(PFS)	Approximately 36 months	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).
6-month PFS rate	Approximately 36 months	6-month progression-free survival (PFS) rate.
Duration Of Response (DOR)	Approximately 36 months	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).
Disease Control Rate (DCR)	Approximately 36 months	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.
Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs)	From the subject signs the ICF to 30 days after the last dose of study drug was administered.	Adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events are included. The investigator should carry out judgment for investigational drug correlation.

Trial Locations

Locations (1)

Chinese People's Liberation Army (PLA) General Hospital; 🇨🇳 Beijing, Beijing, China