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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT03267316
• Date of registration: 24/08/2017
• Prospective Registration: Yes
• Primary sponsor: Cantargia AB
• Public title: A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors CANFOUR
• Scientific 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
• Date of first enrolment: September 19, 2017
• Target sample size: 167
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03267316
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Austria, Belgium, Denmark, Estonia, Germany, Latvia, Lithuania, Netherlands, Norway, Spain, Sweden

Contacts

• Name: Ahmad Awada, Professor
• Affiliation: Jules Bordet Institute, Brussels, Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age = 18 year.

2. Measurable disease in accordance to iRECIST 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 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 diagnosis of unresectable stage III or stage
IV squamous or non-squamous NSCLC (applicable Part II, Combination - NSCLC (NCG) 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.

- 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.

6. Histologically or cytologically confirmed diagnosis of unresectable stage III or stage
IV non-squamous NSCLC (applicable Part II, Combination - non-squamous NSCLC NCP arm
only).

- Subjects must be eligible to receive first line standard chemotherapy regimen
with carboplatin/pemetrexed or a second line standard chemotherapy regimen with
carboplatin/pemetrexed after relapsing from first line with pembrolizumab
monotherapy.

- 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.

7. Newly diagnosed, treatment na?ve, histologically confirmed, unresectable, locally
advanced or metastatic (stage III or stage IV) PDAC (applicable Part II, Combination -
PDAC arms only).

- Subjects must be eligible to receive treatment with nab-paclitaxel and
gemcitabine.

Exclusion Criteria:

1. Subjects receiving live vaccination, etanercept or other TNF-a inhibitors or 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 metastatic 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.

7. Applicable Part II, Combination - NSCLC (NCG and NCP) arms 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pancreatic Ductal Adenocarcinoma

Triple Negative Breast Cancer

Non Small Cell Lung Cancer

Colorectal Cancer

Intervention(s)

Drug: Carboplatin

Drug: Pemetrexed

Drug: Cisplatin

Drug: Nab-paclitaxel

Biological: CAN04

Drug: Gemcitabine

Primary Outcome(s)

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 6 months of treatment, whichever occurs first]

Secondary Outcome(s)

Maximum concentration (Cmax) [Time Frame: 5 weeks]

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

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

Clearance (CL) [Time Frame: 5 weeks]

Anti-drug antibodies (ADA) against CAN04 [Time Frame: Through study completion, an average of 6 months]

Area under the curve from time 0 to infinity (AUC0-8) [Time Frame: 5 weeks]

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

Secondary ID(s)

2017-001111-36

CAN04CLIN001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors