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Trial record 1 of 3 for:    CAN04
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A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors (CANFOUR)

This study is currently recruiting participants.
Verified November 2017 by Cantargia AB
Sponsor:
ClinicalTrials.gov Identifier:
NCT03267316
First Posted: August 30, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cantargia AB
  Purpose

This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors.

Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment. In addition, early signs of efficacy during treatment with CAN04 will be investigated.


Condition Intervention Phase
Non Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Triple Negative Breast Cancer Colorectal Cancer Biological: CAN04 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Part I of the study is designed to define the Maximum Tolerated Dose/ Recommended Phase 2 Dose (MTD/RP2D) of CAN04 in subjects with relapsed or refractory Non-Small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC), Triple Negative Breast Cancer (TNBC) or Colorectal Cancer (CRC).

Part II consists of three treatment arms and aims to establish the safety and tolerability of CAN04 as monotherapy and in combination with the standard of care in subjects with NSCLC or PDAC, as well as to investigate early signs of efficacy.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Escalation Followed by Dose Expansion, Safety and Tolerability Trial of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Subjects With Solid Malignant Tumors

Resource links provided by NLM:


Further study details as provided by Cantargia AB:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 2 months of treatment, whichever occurs first ]
    The incidence of Grade 3 or 4 adverse events (AEs) related to CAN04 administration and according to the National Cancer Institute - Common Terminology Criteria for Ad-verse Events (CTCAE, version 4.03).


Secondary Outcome Measures:
  • Maximum concentration (Cmax) [ Time Frame: 5 weeks ]
    Maximum plasma concentration of CAN04

  • Terminal half-life (t1/2) [ Time Frame: 5 weeks ]
    Terminal half-life of CAN04

  • Clearance (CL) [ Time Frame: 5 weeks ]
    Plasma clearance of CAN04

  • Apparent volume of distribution during the terminal phase (VZ) [ Time Frame: 5 weeks ]
    Apparent volume of distribution of CAN04 during the terminal phase

  • Area under the curve from time 0 to infinity (AUC0-∞) [ Time Frame: 5 weeks ]
    Area under the plasma concentration curve from time 0 to infinity

  • Anti-drug antibodies (ADA) against CAN04 [ Time Frame: Through study completion, an average of 6 months ]
    Immunogenicity of CAN04 after repeated administrations, assessed by ADA titers in serum.

  • Preliminary signs of efficacy as assessed by tumor response [ Time Frame: One year ]
    Tumor response.


Estimated Enrollment: 65
Actual Study Start Date: September 19, 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose escalation
Cohorts of 3 subjects will receive once weekly (Q1W) treatment with CAN04. The Dose Limiting Toxicity (DLT) observation period for each dose level will be the first 21 days of treatment with CAN04.
Biological: CAN04
A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.
Experimental: Monotherapy
Subjects with either PDAC or NSCLC, will receive treatment with CAN04 monotherapy.
Biological: CAN04
A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.
Experimental: Combination
Subjects with PDAC or NSCLC, will receive once weekly treatment with CAN04 in combination with standard-of-care therapy (TBD).
Biological: CAN04
A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.

Detailed Description:

CAN04 is a first-in-class fully humanized and ADCC enhanced monoclonal antibody, targeting the Interleukin 1 Receptor Accessory Protein (IL1RAP).

The CAN04 strategy is to attack the IL1RAP target molecule using an effective antibody-based cancer treatment. In preclinical (in vitro and in vivo) studies, CAN04 has shown two distinct mechanisms of action:

  1. By blocking the intracellular signals from the IL1RAP target molecule, thereby impairing the cancer cells' ability to secrete tumor stimulating cytokines, in turn reducing tumor inflammation and tumor progression.
  2. Through antibody dependent cellular cytotoxicity (ADCC) against IL1RAP expressing tumor cells where CAN04 stimulates natural killer (NK) cells to attack the tumor cells.

The study is a combined phase 1/2a, open-label, dose-escalation followed by dose expansion, safety and tolerability clinical trial, in patients with relapsed or refractory solid tumors. It consists of two parts.

In Part I (Dose Escalation - DE), the intention is to include patients with any of the four solid tumor types: Non-Small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC), Triple Negative Breast Cancer (TNBC) or Colorectal Cancer (CRC). In this part of the study safety and tolerability will be documented and the MTD/ RP2D will be determined. Patients will stay on CAN04 treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason.

In Part II (Expansion Cohort - EC), safety and tolerability will be further evaluated in an expanded cohort of subjects with PDAC or NSCLC at the RP2D level. In addition, early signs of efficacy during treatment with CAN04 will be investigated, as monotherapy or in combination with the standard of care.

Patients will stay on treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 year.
  2. Measurable disease in accordance to immune related Response Criteria (irRC) by computed tomography (CT) or magnetic resonance imaging (MRI) scan, no more than 6 weeks prior to screening.
  3. At least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies.
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  5. Histologically or cytologically confirmed, locally advanced, metastatic NSCLC, PDAC, CRC or TNBC tumor, relapsed or refractory to standard therapy or for which there is no standard therapy. CRC and TNBC not allowed in second part.

Exclusion Criteria:

  1. Subjects receiving any other investigational agents during or just prior to (within 28 days of first study drug administration) participation in this study.
  2. Clinical evidence of an active second malignancy.
  3. Subjects with a life expectancy <12 weeks.
  4. Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III, or IV.
  5. Immunocompromised subject currently receiving systemic therapy.
  6. Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267316


Contacts
Contact: Lars Thorsson, PhD +46 46 275 62 60 lars.thorsson@cantargia.com
Contact: Susanne Magnusson, PhD

Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Christiane Jungels, Dr    +32 2 541 7342    christiane.jungels@bordet.be   
Denmark
Rigshospitalet, Department of Oncology Recruiting
Copenhagen, Denmark, 2100
Contact: Morten Mau Sorensen, Dr.    +45 354 508 79    mms@rh.regionh.dk   
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Jan H.M. Schellens, Prof. Dr.    +31 20 512 9111    j.schellens@nki.nl   
Erasmus University Medical Center, Department of Medical Oncology Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Ferry ALM Eskens, MD, PhD    +31 10 703 48 97    f.eskens@erasmusmc.nl   
Norway
Oslo University Hospital, Radiumhospitalet Recruiting
Oslo, Norway, 0379
Contact: Tormod Kyrre Guren, Dr.    +47 2 541 3188    uxtour@ous-hf.no   
Sponsors and Collaborators
Cantargia AB
Investigators
Principal Investigator: Ahmad Awada, Professor Jules Bordet Institute, Brussels, Belgium
  More Information

Responsible Party: Cantargia AB
ClinicalTrials.gov Identifier: NCT03267316     History of Changes
Other Study ID Numbers: CAN04CLIN001
2017-001111-36 ( EudraCT Number )
First Submitted: August 24, 2017
First Posted: August 30, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cantargia AB:
CAN04
First-in-Human
Phase 1
Phase 2
Antibody, Monoclonal
IL1RAP
Safety
Tolerability
Cancer
Solid tumor
Malignant
Dose escalation
Dose expansion
Immunoglobulin
Clinical Trial
Infusion
Antineoplastic
Anticancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Adenocarcinoma
Triple Negative Breast Neoplasms
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Immunoglobulins
Immunologic Factors