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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT06261359

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

A Phase 2 study testing CEND-1, Gemcitabine and Nab paclitaxel in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
CEND-1, Gemcitabine and Nab paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
19 Mar 2024to Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianming Xu, M.D contact

13910866712

Jianmingxu2014@163.com

China1 site, 1 recruiting

  • Chinese People's Liberation Army (PLA) General Hospital

    Beijing, Beijing Municipality, 100000

    Xu Jianming, M.D, 13910866712, Jianmingxu2014@163.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
CEND-1, Gemcitabine, Nab paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEND-1Drug

    Also called iRGD, LSTA1, certepetide

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

  • GemcitabineDrug

    Also called Gemzar

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

  • Nab paclitaxelDrug

    Also called Abraxane

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

Study groups in NCT06261359
Study groupRoleWhat they receive
CEND-1+ nab-paclitaxel + gemcitabineExperimentalParticipants 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.
Receives: Drug: CEND-1; Drug: Gemcitabine; Drug: Nab paclitaxel
Placebo+ nab-paclitaxel + gemcitabinePlacebo comparatorParticipants 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.
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 36 months

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS is defined as the duration from randomization to the time point when death occurs due to any cause.

    Measured: Approximately 36 months

  2. 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).

    Measured: Approximately 36 months

  3. 6-month PFS rate

    6-month progression-free survival (PFS) rate.

    Measured: Approximately 36 months

  4. 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).

    Measured: Approximately 36 months

  5. 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.

    Measured: Approximately 36 months

  6. 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.

    Measured: From the subject signs the ICF to 30 days after the last dose of study drug was administered.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start19 Mar 2024
  3. Primary completionApr 2025 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261359
Sponsor's protocol ID
CEND1-202
Status last verified
Nov 2023
First submitted
7 Feb 2024
Last updated
4 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CEND-1, Gemcitabine and Nab paclitaxel in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianming Xu, M.D (13910866712, Jianmingxu2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Approximately 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06261359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.

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