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

NCT06261359 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-09-04

No results posted yet for this study

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)

Interventions

DRUG

CEND-1

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

DRUG

Gemcitabine

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

DRUG

Nab paclitaxel

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2025-04-30
Completion
2026-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261359 on ClinicalTrials.gov