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Advanced Pancreatic Ductal AdenocarcinomaPhase 3NCT05149326

KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

A Phase 3 study testing KN046 in people with Advanced Pancreatic Ductal Adenocarcinoma, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 65 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multicenter, randomized, double-Blind Phase III Study to compare the clinical efficacy and safety of KN046 plus gemcitabine and nab-paclitaxel versus placebo plus gemcitabine and nab-paclitaxel in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
KN046
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
65 sitesChina
Study dates
20 Jan 2022to 30 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18, male or female;
  • Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
  • Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
  • Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
  • Has a life expectancy of at least 3 months;
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  • Has adequate organ function;
  • If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
  • If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

Who cannot join

  • Untreated active CNS metastasis or leptomeningeal metastasis.
  • Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
  • Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
  • Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
  • Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
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  • Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
  • Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
  • History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
  • Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
  • Is pregnant or breastfeeding;
  • Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

China65 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Southwest Hospital of AMU

    Chongqing, Chongqing Municipality

  • The Third Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Second Affiliated Hosipital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The Second Hospital Of Anhui medical University

    Hefei, Anhui

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • LINYI Cancer Hospital

    Linyi, Shandong

  • Linyi City People Hospital

    Linyi, Shandong

  • First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Nantong Tumor Hospital

    Nantong, Jiangsu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine , Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Cancer hospital

    Taiyuan, Shanxi

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

  • Weifang People'S Hospital

    Weifang, Shandong

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • Union Hospital Tongji Medical College Huazhong University of Science And Technology

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • the First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The Affiliated Hospital Of XuZhou Medical University

    Xuzhou, Jiangsu

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Gemcitabine and Nab-Paclitaxel Versus Placebo Combined With Gemcitabine and Nab-Paclitaxel in First Line Advanced Pancreatic Ductal Adenocarcinoma Subjects (ENREACH-PDAC-01).

This study is a multicenter, randomized, double-Blind Phase III Study to compare the clinical efficacy and safety of KN046 plus gemcitabine and nab-paclitaxel versus placebo plus gemcitabine and nab-paclitaxel in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.

Being tested
KN046, placebo

What participants receive

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

  • KN046Drug

    KN046+Nab-Paclitaxel+Gemcitabine In combine therapy stage, KN046 is 5 milligram per kilogram, every 2 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.

  • placeboDrug

    placebo+Nab-Paclitaxel+Gemcitabine In combine therapy stage, placebo is 5 milligram per kilogram, every 2 weeks. In maintain stage, placebo is 5 milligram per kilogram, every 2 weeks.

Study groups in NCT05149326
Study groupRoleWhat they receive
Experimental armExperimentalNot described
Receives: Drug: KN046
Control armPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.

    Measured: up to 2 years

Secondary outcomes (2)

  1. Progression-free survival (PFS)

    Time between randomization to date of disease progression or death due to any cause.

    Measured: up to 2 years

  2. Overall response rate (ORR)

    Complete Response or Partial Response according to RECIST

    Measured: up to 2 years

Timeline

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

  1. First posted8 Dec 2021
  2. Study start20 Jan 2022
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Aug 2024 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05149326
Sponsor's protocol ID
KN046-303
Status last verified
Mar 2024
First submitted
26 Nov 2021
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KN046 in people with Advanced Pancreatic Ductal Adenocarcinoma, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 65 sites 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 12 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: up to 2 years). 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 NCT05149326.

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 26 Mar 2024.

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