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A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors (CANFOUR)

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ClinicalTrials.gov Identifier: NCT03267316
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Cantargia AB

August 24, 2017
August 30, 2017
November 8, 2017
September 19, 2017
September 2019   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT03267316 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
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

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.

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.

Interventional
Phase 1
Phase 2
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
  • Non Small Cell Lung Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Triple Negative Breast Cancer
  • Colorectal Cancer
Biological: CAN04
A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.
  • 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.
    Intervention: Biological: CAN04
  • Experimental: Monotherapy
    Subjects with either PDAC or NSCLC, will receive treatment with CAN04 monotherapy.
    Intervention: Biological: CAN04
  • Experimental: Combination
    Subjects with PDAC or NSCLC, will receive once weekly treatment with CAN04 in combination with standard-of-care therapy (TBD).
    Intervention: Biological: CAN04
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
65
Same as current
March 2020
September 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Lars Thorsson, PhD +46 46 275 62 60 lars.thorsson@cantargia.com
Contact: Susanne Magnusson, PhD
Belgium,   Denmark,   Netherlands,   Norway
 
 
NCT03267316
CAN04CLIN001
2017-001111-36 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Cantargia AB
Cantargia AB
Not Provided
Principal Investigator: Ahmad Awada, Professor Jules Bordet Institute, Brussels, Belgium
Cantargia AB
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP