Non Small Cell Lung CancerPhase 1/2CANFOURNCT03267316
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
A Phase 1/2 study testing CAN04, Cisplatin and Gemcitabine in people with Non Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma, run by Cantargia AB at 25 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple Negative Breast Cancer
- What is being tested?
- CAN04, Cisplatin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 25 sitesin 11 countries
- Study dates
- 19 Sep 2017to 14 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (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.
Show all 12Show fewer
- 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.
- 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.
- Newly diagnosed, treatment naїve, 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.
Who cannot join
- Subjects receiving live vaccination, etanercept or other TNF-α 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
25 sites in 11 countries.
25 sites in 11 countries
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Rigshospitalet, Department of Oncology
Copenhagen, 2100
Herlev og Gentofte Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
University Hospital Gasthuisberg
Leuven, 3000
CHU de Liège
Liège, B-4000
Germany3 sites
Charité Universitätsmedizin Berlin
Berlin, 10117
Asklepios Klinik Altona
Hamburg, 227 63
Universitätsklinikum Ulm
Ulm, 89081
Spain3 sites
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
Hospital Universitario Central de Asturias
Oviedo, 33011
Austria2 sites
Landeskrankenhaus Salzburg
Salzburg, 5020
Medizinische Universität Wien
Vienna, A-1090
Estonia2 sites
East Tallinn Central Hospital
Tallinn, 11312
Tartu University Hospital
Tartu, 50406
Latvia2 sites
Pauls Stradiņš Clinical University Hospital
Riga, 1002
Riga East Clinical University Hospital
Riga, 1079
Lithuania2 sites
The Hospital of Lithuanian University of Health Sciences
Kaunas, 50161
National Cancer Institute
Vilnius, 08660
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, 1066 CX
Erasmus University Medical Center, Department of Medical Oncology
Rotterdam, 3015 CE
About this study
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
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 and 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.
Read the 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:
- 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.
- 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 to identify RP2D of CAN04 in combination with standard of care. 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 all arms completed]
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple Negative Breast Cancer, Colorectal Cancer
- Being tested
- CAN04, Cisplatin, Gemcitabine, Nab-paclitaxel, Carboplatin
- Keywords
- First-in-Human, Phase 1, Phase 2, Antibody, Monoclonal, IL1RAP, Safety, Tolerability, Cancer, Solid tumor, Malignant, Dose escalation, Dose expansion, CAN04, Immunoglobulin, Clinical Trial, Infusion, Antineoplastic, Anticancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN04Biological
A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.
CisplatinDrug
Standard of care treatment
GemcitabineDrug
Standard of care treatment
Nab-paclitaxelDrug
Standard of care treatment
CarboplatinDrug
Standard of care treatment
PemetrexedDrug
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | 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. [Completed December 2018] Receives: Biological: CAN04 |
| Monotherapy (Q1W) | Experimental | Subjects with either PDAC or NSCLC, will receive treatment with CAN04 monotherapy once weekly (Q1W). Receives: Biological: CAN04 |
| Monotherapy (Q1W/Q2W) | Experimental | Subjects with either PDAC or NSCLC, will receive treatment with CAN04 monotherapy once weekly (Q1W) for the first 6 weeks followed by treatment every second week (Q2W). Receives: Biological: CAN04 |
| Combination - NSCLC (NCG) | Experimental | Subjects with NSCLC will receive treatment with CAN04 once weekly (Q1W) for the first 6 weeks followed by treatment every second week (Q2W) in combination with standard-of-care therapy (cisplatin/gemcitabine). Receives: Biological: CAN04; Drug: Cisplatin; Drug: Gemcitabine |
| Combination - PDAC | Experimental | Subjects with PDAC will receive treatment with CAN04 once weekly (Q1W) for the first 6 weeks followed by treatment every second week (Q2W) in combination with standard-of-care therapy (nab-paclitaxel/gemcitabine). Receives: Biological: CAN04; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| Combination - PDAC (1 mg/kg) | Experimental | Subjects with PDAC will receive CAN04 on Day 1 and 15 in cycles of 28 days in combination with standard-of-care therapy (nab-paclitaxel/gemcitabine). During first cycle CAN04 also to be administered on Day 8. Receives: Biological: CAN04; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| Combination - PDAC (2,5 mg/kg) | Experimental | Subjects with PDAC will receive CAN04 on Day 1 and 15 in cycles of 28 days in combination with standard-of-care therapy (nab-paclitaxel/gemcitabine). During first cycle CAN04 also to be administered on Day 8. Receives: Biological: CAN04; Drug: Gemcitabine; Drug: Nab-paclitaxel |
| Combination - non-squamous NSCLC (NCP) | Experimental | Subjects with non-squamous NSCLC will receive CAN04 on Day 1 and 8 in cycles of 21 days in combination with standard-of-care therapy (carboplatin/pemetrexed). Receives: Biological: CAN04; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
The incidence of Grade 3 or higher adverse events (AEs) related to CAN04 administration and according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
Measured: 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 outcomes (7)
Maximum concentration (Cmax)
Maximum plasma concentration of CAN04
Measured: 5 weeks
Terminal half-life (t1/2)
Terminal half-life of CAN04
Measured: 5 weeks
Clearance (CL)
Plasma clearance of CAN04
Measured: 5 weeks
Apparent volume of distribution during the terminal phase (VZ)
Apparent volume of distribution of CAN04 during the terminal phase
Measured: 5 weeks
Area under the curve from time 0 to infinity (AUC0-∞)
Area under the plasma concentration curve from time 0 to infinity
Measured: 5 weeks
Anti-drug antibodies (ADA) against CAN04
Immunogenicity of CAN04 after repeated administrations, assessed by ADA titers in serum.
Measured: Through study completion, an average of 6 months
Preliminary signs of efficacy as assessed by tumor response
Tumor response (irRC Part I Part II Monotherapy arms; iRECIST Part II Combination arms)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start19 Sep 2017
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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). \[Completed December 2018\] Part II consists of seven 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 \[Enrollment to all arms completed\].
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantargia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmad Awada, Professor, Principal investigator, Jules Bordet Institute, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267316
- Sponsor's protocol ID
- CAN04CLIN001
- Other IDs
- 2017-001111-36, 2017
- Acronym
- CANFOUR
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2017
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paulus A, Zemaitis M, Cicenas S, Zvirbule Z, Sanfridson A, Millrud CR, Magnusson S, Losic N, Tersago D, Garcia-Ribas I, Thorsson L, Paz-Ares LG. Safety, efficacy, and analysis of biomarkers in patients with advanced non-small cell lung cancer treated with the anti-IL1RAP antibody nadunolimab (CAN04) in combination with platinum doublet. Lung Cancer. 2025 Aug;206:108664. doi: 10.1016/j.lungcan.2025.108664. Epub 2025 Jul 14.
PubMed 40680438Robbrecht D, Jungels C, Sorensen MM, Spanggaard I, Eskens F, Fretland SO, Guren TK, Aftimos P, Liberg D, Svedman C, Thorsson L, Steeghs N, Awada A. First-in-human phase 1 dose-escalation study of CAN04, a first-in-class interleukin-1 receptor accessory protein (IL1RAP) antibody in patients with solid tumours. Br J Cancer. 2022 Apr;126(7):1010-1017. doi: 10.1038/s41416-021-01657-7. Epub 2021 Dec 13.
PubMed 34903842
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03267316
- Acronym / sponsor ID
- CANFOUR / CAN04CLIN001
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple Negative Breast Cancer, Colorectal Cancer
- Keywords
- First-in-Human, Phase 1, Phase 2, Antibody, Monoclonal, IL1RAP, Safety, Tolerability, Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Cantargia ABIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and 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.
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:
- 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.
- 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 to identify RP2D of CAN04 in combination with standard of care. 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 all arms completed]
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- 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). [Completed December 2018] Part II consists of seven 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 [Enrollment to all arms completed].
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Biological: CAN04Cohorts 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. [Completed December 2018] |
| Monotherapy (Q1W) | Experimental | Biological: CAN04Subjects with either PDAC or NSCLC, will receive treatment with CAN04 monotherapy once weekly (Q1W). |
| Monotherapy (Q1W/Q2W) | Experimental | Biological: CAN04Subjects with either PDAC or NSCLC, will receive treatment with CAN04 monotherapy once weekly (Q1W) for the first 6 weeks followed by treatment every second week (Q2W). |
| Combination - NSCLC (NCG) | Experimental | Biological: CAN04, Drug: Cisplatin, Drug: GemcitabineSubjects with NSCLC will receive treatment with CAN04 once weekly (Q1W) for the first 6 weeks followed by treatment every second week (Q2W) in combination with standard-of-care therapy (cisplatin/gemcitabine). |
| Combination - PDAC | Experimental | Biological: CAN04, Drug: Gemcitabine, Drug: Nab-paclitaxelSubjects with PDAC will receive treatment with CAN04 once weekly (Q1W) for the first 6 weeks followed by treatment every second week (Q2W) in combination with standard-of-care therapy (nab-paclitaxel/gemcitabine). |
| Combination - PDAC (1 mg/kg) | Experimental | Biological: CAN04, Drug: Gemcitabine, Drug: Nab-paclitaxelSubjects with PDAC will receive CAN04 on Day 1 and 15 in cycles of 28 days in combination with standard-of-care therapy (nab-paclitaxel/gemcitabine). During first cycle CAN04 also to be administered on Day 8. |
| Combination - PDAC (2,5 mg/kg) | Experimental | Biological: CAN04, Drug: Gemcitabine, Drug: Nab-paclitaxelSubjects with PDAC will receive CAN04 on Day 1 and 15 in cycles of 28 days in combination with standard-of-care therapy (nab-paclitaxel/gemcitabine). During first cycle CAN04 also to be administered on Day 8. |
| Combination - non-squamous NSCLC (NCP) | Experimental | Biological: CAN04, Drug: Carboplatin, Drug: PemetrexedSubjects with non-squamous NSCLC will receive CAN04 on Day 1 and 8 in cycles of 21 days in combination with standard-of-care therapy (carboplatin/pemetrexed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 (NCG) arm only).
Key exclusion criteria (10 listed)
- Subjects receiving live vaccination, etanercept or other TNF-α 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAN04A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion. | Biological | Combination - NSCLC (NCG), Combination - PDAC, Combination - PDAC (1 mg/kg), Combination - PDAC (2,5 mg/kg), Combination - non-squamous NSCLC (NCP), Dose escalation, Monotherapy (Q1W), Monotherapy (Q1W/Q2W) |
| CisplatinStandard of care treatment | Drug | Combination - NSCLC (NCG) |
| GemcitabineStandard of care treatment | Drug | Combination - NSCLC (NCG), Combination - PDAC, Combination - PDAC (1 mg/kg), Combination - PDAC (2,5 mg/kg) |
| Nab-paclitaxelStandard of care treatment | Drug | Combination - PDAC, Combination - PDAC (1 mg/kg), Combination - PDAC (2,5 mg/kg) |
| CarboplatinStandard of care treatment | Drug | Combination - non-squamous NSCLC (NCP) |
| PemetrexedStandard of care treatment | Drug | Combination - non-squamous NSCLC (NCP) |
Primary outcome
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
The incidence of Grade 3 or higher adverse events (AEs) related to CAN04 administration and according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
7 secondary outcomes
Maximum concentration (Cmax)
Time frame: 5 weeks
Terminal half-life (t1/2)
Time frame: 5 weeks
Clearance (CL)
Time frame: 5 weeks
Apparent volume of distribution during the terminal phase (VZ)
Time frame: 5 weeks
Area under the curve from time 0 to infinity (AUC0-∞)
Time frame: 5 weeks
Anti-drug antibodies (ADA) against CAN04
Time frame: Through study completion, an average of 6 months
Preliminary signs of efficacy as assessed by tumor response
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 40680438Paulus A, Zemaitis M, Cicenas S, Zvirbule Z, Sanfridson A, Millrud CR, Magnusson S, Losic N, Tersago D, Garcia-Ribas I, Thorsson L, Paz-Ares LG. Safety, efficacy, and analysis of biomarkers in patients with advanced non-small cell lung cancer treated with the anti-IL1RAP antibody nadunolimab (CAN04) in combination with platinum doublet. Lung Cancer. 2025 Aug;206:108664. doi: 10.1016/j.lungcan.2025.108664. Epub 2025 Jul 14.
- Derived from this study: PubMed 34903842Robbrecht D, Jungels C, Sorensen MM, Spanggaard I, Eskens F, Fretland SO, Guren TK, Aftimos P, Liberg D, Svedman C, Thorsson L, Steeghs N, Awada A. First-in-human phase 1 dose-escalation study of CAN04, a first-in-class interleukin-1 receptor accessory protein (IL1RAP) antibody in patients with solid tumours. Br J Cancer. 2022 Apr;126(7):1010-1017. doi: 10.1038/s41416-021-01657-7. Epub 2021 Dec 13.
- Poster presentation at ESMO 2018Link provided by the sponsor.
- Oral presentation at ASCO annual meeting 2019Link provided by the sponsor.
- Poster presentation at ESMO 2021Link provided by the sponsor.
- Poster presentation at ASCO annual meeting 2022Link provided by the sponsor.
- Poster presentation at ASCO annual meeting 2022Link provided by the sponsor.
- Poster presentation at AACR annual meeting 2023Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Awada, Professor principal investigator
Jules Bordet Institute, Brussels, Belgium
25 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAN04, Cisplatin and Gemcitabine in people with Non Small Cell Lung Cancer and Pancreatic Ductal Adenocarcinoma, run by Cantargia AB at 25 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Denmark, Belgium, Germany, Spain, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 6 months of treatment, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267316, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.