NCT05149326|Active Not RecruitingPhase 3DMC

KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

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).

Jiangsu Alphamab Biopharmaceuticals Co., Ltd ClinicalTrials.gov

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1 other identifier

KN046-303

Study Type

interventional

Target

408

Locations

1 country

Sites

Timeline

RegisteredDec 2021

StartedJan 2022

CompletionAug 2024

Brief 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 treatment.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

408

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jan 2022

Typical duration for phase_3

Geographic Reach

1 country

65 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

November 26, 2021

Completed

12 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed

1 month until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed

Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

November 26, 2021

Last Update Submit

March 24, 2024

Conditions

Advanced Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (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.
up to 2 years

Secondary Outcomes (2)

Progression-free survival (PFS)
up to 2 years
Overall response rate (ORR)
up to 2 years

Study Arms (2)

Experimental arm

EXPERIMENTAL

Drug: KN046

Control arm

PLACEBO COMPARATOR

Drug: placebo

Interventions

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.

Experimental arm

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.

Control arm

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;
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.

You may not qualify if:

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);
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Jiangsu Alphamab Biopharmaceuticals Co., Ltdlead

Study Sites (65)

The Second Hospital Of Anhui medical University

Hefei, Anhui, China

Location

Beijing Cancer Hospital