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

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    140
  • sponsor
    Cantargia AB
Updated on 29 January 2022
ct scan
paclitaxel
cancer
measurable disease
lung cancer
gemcitabine
pembrolizumab
EGFR
chemotherapy regimen
cancer chemotherapy
pdac
platinum doublet
lung carcinoma

Summary

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, to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated.

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. [Completed December 2018]

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. [Enrollment to monotherapy arms completed]

Details
Condition Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple Negative Breast Cancer, Colorectal Cancer
Treatment cisplatin, Gemcitabine, Nab-paclitaxel, CAN04
Clinical Study IdentifierNCT03267316
SponsorCantargia AB
Last Modified on29 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 year
Measurable disease in accordance to iRECIST by computed tomography (CT) or magnetic resonance imaging (MRI) scan, no more than 6 weeks prior to screening
At least 4 weeks since the last dose of 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
Eastern Cooperative Oncology Group (ECOG) performance status 1
Histologically or cytologically confirmed diagnosis of unresectable stage III or stage IV squamous or non-squamous NSCLC (applicable Part II, Combination - NSCLC arm only)
Subjects must be eligible to receive first line standard chemotherapy regimen with cisplatin/gemcitabine or a second line standard chemotherapy regimen with cisplatin/gemcitabine after relapsing from first line with pembrolizumab monotherapy
Newly diagnosed, treatment nave, histologically confirmed, unresectable, locally advanced or metastatic (stage III or stage IV) PDAC (applicable Part II, Combination - PDAC arm only)
Subjects with actionable mutations (EGFR, ALK, ROS) can be enrolled if they have previously progressed to all approved standard of care targeted therapies and the next line of standard therapy is a platinum doublet
Subjects must be eligible to receive treatment with nab-paclitaxel and gemcitabine

Exclusion Criteria

Subjects receiving live vaccination, etanercept or other TNF- inhibitors or any other investigational agents during or just prior to (within 28 days of first study drug administration) participation in this study
Clinical evidence of an active metastatic second malignancy
Subjects with a life expectancy <12 weeks
Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III, or IV
Immunocompromised subject currently receiving systemic therapy
Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion
Applicable Part II, Combination - NSCLC arm only
Prior lines of treatment with anti-cancer medication other than pembrolizumab administered as 1st line
Known tumor EGFR mutation, unless contraindication to EGFR-directed therapy or if the subject has progressed to all approved anti-EGFR therapies
Known tumor ALK rearrangements, unless contraindication to ALK-directed therapy or ALK-directed therapy not available or if the subject has progressed to all approved anti-EGFR therapies
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