Metastatic Pancreatic Ductal AdenocarcinomaPhase 1CAPAFOURNCT04990037
A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing CAN04 and FOLFIRINOX in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Cantargia AB at 9 sites in 2 countries.
Trial summary
This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- CAN04 and FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 19 Jul 2021to 15 Jun 2023
- Phase
- Phase 1
- 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
- The subject is capable to understand and willing to provide written informed consent before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the subject's disease).
- The subject is at least 18 years of age.
- The subject has been diagnosed with stage IV PDAC (Pancreatic Ductal Adenocarcinoma) and is amenable to first-line systemic therapy. The subject must have measurable disease that is histologically or cytologically confirmed.
- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
- The subject has a primary or metastatic lesion amenable to biopsy and is willing to undergo repeat biopsies, unless a biopsy would not be safe in the opinion of the investigator and in agreement by the sponsor and medical monitor (or designee).
- The subject has clinically adequate bone marrow, hepatic, and renal function based on clinical laboratory test values at screening within the following ranges:
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- Creatinine clearance >30 mL/min calculated by Cockcroft-Gault formula
- Haemoglobin >90 g/L (blood transfusions during the screening period are not allowed)
- Absolute neutrophil count >1.5 × 109/L (usage of growth factors, such as G-CSF (Granulocyte Colony-Stimulating Factor), during the screening period is not allowed)
- Platelets >100 × 109/L
- Total bilirubin <1.5 × ULN unless due to Gilbert's syndrome
- AST and ALT ≤3 × ULN (or <5 × ULN for subjects with hepatic metastases)
- The subject has a QT interval corrected using Fridericia's formula (QTcF) of ≤ 480 milliseconds at screening.
- Female subjects of childbearing potential (more info can be found in the protocol) and male subjects with female partners of childbearing potential must be willing to adhere to contraceptive requirements as detailed in the protocol, from at least 1 month prior to study entry to at least 4 months after the last dose of study treatment.
- The subject has suitable venous access for safe drug administration and the study- required drug concentration and pharmacodynamic sampling.
Who cannot join
- Subjects who have received previous radical radiotherapy, chemotherapy, or investigational therapy for the treatment of metastatic disease.
- Prior treatment with 5-FU or gemcitabine administered as a radiation sensitiser during and up to 4 weeks after radiation therapy, is allowed; however, if there is lingering toxicity (Grade >1), then the sponsor should be consulted.
- If a subject received adjuvant or neoadjuvant chemotherapy, tumour recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose.
- Subjects with uncontrolled brain metastases; however, subjects are allowed if they have been previously treated with surgery, whole-brain radiation, and/or stereotactic radiosurgery and are considered controlled (with ≤10 mg/day of prednisone or equivalent) at the time of receiving the first dose of CAN04. For asymptomatic subjects, screening brain imaging is not required.
- Subjects with endocrine or acinar pancreatic carcinoma.
- Subjects with an active severe infection requiring parenteral antibiotics at the time of enrolment or subjects currently receiving oral antibiotics as a continuation of a previous course of parenteral antibiotics.
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- Subjects with peripheral sensory neuropathy Grade ≥2.
- Subjects with a serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the subject to participate in the study or that might jeopardise compliance with the protocol.
- Subjects with psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs (Adverse Events) or has compromised ability to provide written informed consent.
- Subjects with an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting.
- Subjects with uncontrolled or significant cardiovascular disease defined as NYHA (New York Heart Association) classification III or IV.
- Subjects with congenital long QT syndrome.
- Subjects with a history of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses >10 mg/day).
- Subjects with known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. NOTE: Subjects who have positive hepatitis B core antibody or hepatitis B surface antigen antibody can be included but must have an undetectable hepatitis B viral load.
- Subjects with a known history of any other relevant congenital or acquired immunodeficiency other than HIV infection. NOTE: Subjects testing positive for HIV are NOT excluded from this study, but HIV- positive subjects must meet the following criteria:
- Have CD4+ T-cell (CD4+) counts ≥350 cells/µL.
- Have not had an opportunistic infection within the past 12 months. Subjects on prophylactic antimicrobials can be included in the study.
- Should be on established antiretroviral therapy for at least 4 weeks.
- Have an HIV viral load less than 400 copies/mL prior to enrolment.
- Subjects who receive a live vaccination, etanercept, or other TNF-α (Tumor Necrosis Factor-alpha) inhibitors during or just prior to (within 28 days of first dose of study treatment) participation in this study.
- Subjects who have had a hospitalization for bowel obstruction within 12 weeks prior to enrolment.
- Subjects with a known bleeding disorder or coagulopathy. NOTE: Subjects on stable anticoagulant therapy are allowed at the discretion of the investigator; however, these subjects should be monitored more frequently.
- Subjects with a known or suspected allergy to any study treatment or related products, including platinum-based chemotherapeutic agents.
- Female subjects who are pregnant or breastfeeding or trying to become pregnant.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Spain5 sites
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON
Barcelona, 08035
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
Hospital General Universitario Gregorio Maranon
Madrid, 28007
START MADRID_Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
France4 sites
EDOG - Institut Bergonie - PPDS
Bordeaux, 33000
EDOG Institut de Cancerologie de l'Ouest - PPDS
Nantes, 44100
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes
Institut de Cancerologie de l'Ouest
Saint-Herblain, 44805
About this study
Official title: A Phase 1b Dose Escalation and Expansion Study of CAN04, a Monoclonal Antibody Targeting IL1RAP, in Combination With Modified FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.
- Being tested
- CAN04, FOLFIRINOX
- Keywords
- Carcinoma, Adenocarcinoma, Pancreatic Cancer, Metastatic
- Medical subject headings
- Carcinoma, Adenocarcinoma, Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN04Drug
Also called Nadunolimab
Administered intravenously
FOLFIRINOXDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| CAN04 and FOLFIRINOX | Experimental | Subjects will receive bi-weekly doses of CAN04 in combination with FOLFIRINOX given as standard regimen. Receives: Drug: CAN04; Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of TEAEs (Treatment-emergent adverse events)
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 comes first.
Number of participants with DTLs (dose-limiting toxicities)
Measured: Up to day 28
Number of subjects with 1 or more TEAEs leading to dose modifications
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 comes first.
Number of subjects with grade ≥ 3 TEAEs
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 comes first.
Percentage of subjects with grade ≥ 3 TEAEs
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 comes first.
Number of subjects with 1 or more TEAEs leading to treatment discontinuation
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 comes first.
Percentage of subjects with 1 or more TEAEs leading to dose modification
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 comes first.
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation
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 comes first.
Number of subjects with 1 or more SAEs (serious adverse events)
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 comes first.
Percentage of subjects with 1 or more SAEs
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 comes first.
Secondary outcomes (7)
Serum Concentrations of CAN04 and Folfirnox
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 comes first.
Antidrug antibodies (ADAs) against CAN04
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 comes first.
Change in serum IL-6 (Interleukin-6) concentration
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 comes first.
Change in serum CRP (C-reactive protein) concentration
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 comes first.
Overall response rate (ORR)
Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI Scan)
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 comes first.
Progression free survival
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 comes first.
Overall Survival
Measured: Up to 36 months after 1st dose of last subject (or death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start19 Jul 2021
- Primary completion30 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantargia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignacio Garcia-Ribas, MD, PhD, Study director, Cantargia AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990037
- Sponsor's protocol ID
- CAN04CLIN003
- Acronym
- CAPAFOUR
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose Escalation and Expansion Study of CAN04, a Monoclonal Antibody Targeting IL1RAP, in Combination With Modified FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04990037
- Acronym / sponsor ID
- CAPAFOUR / CAN04CLIN003
- Keywords
- Carcinoma, Adenocarcinoma, Pancreatic Cancer, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cantargia ABIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 4 Aug 2021 (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 consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAN04 and FOLFIRINOX | Experimental | Drug: CAN04, Drug: FOLFIRINOXSubjects will receive bi-weekly doses of CAN04 in combination with FOLFIRINOX given as standard regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject is capable to understand and willing to provide written informed consent before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the subject's disease).
- The subject is at least 18 years of age.
- The subject has been diagnosed with stage IV PDAC (Pancreatic Ductal Adenocarcinoma) and is amenable to first-line systemic therapy. The subject must have measurable disease that is histologically or cytologically confirmed.
- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
- The subject has a primary or metastatic lesion amenable to biopsy and is willing to undergo repeat biopsies, unless a biopsy would not be safe in the opinion of the investigator and in agreement by the sponsor and medical monitor (or designee).
Key exclusion criteria (24 listed)
- Subjects who have received previous radical radiotherapy, chemotherapy, or investigational therapy for the treatment of metastatic disease.
- Subjects with uncontrolled brain metastases; however, subjects are allowed if they have been previously treated with surgery, whole-brain radiation, and/or stereotactic radiosurgery and are considered controlled (with ≤10 mg/day of prednisone or equivalent) at the time of receiving the first dose of CAN04. For asymptomatic subjects, screening brain imaging is not required.
- Subjects with endocrine or acinar pancreatic carcinoma.
- Subjects with an active severe infection requiring parenteral antibiotics at the time of enrolment or subjects currently receiving oral antibiotics as a continuation of a previous course of parenteral antibiotics.
- Subjects with peripheral sensory neuropathy Grade ≥2.
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 |
|---|---|---|
| CAN04Also: NadunolimabAdministered intravenously | Drug | CAN04 and FOLFIRINOX |
| FOLFIRINOXAdministered intravenously | Drug | CAN04 and FOLFIRINOX |
Primary outcome
Frequency of TEAEs (Treatment-emergent adverse events)
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 comes first.
Number of participants with DTLs (dose-limiting toxicities)
Time frame: Up to day 28
Number of subjects with 1 or more TEAEs leading to dose modifications
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 comes first.
Number of subjects with grade ≥ 3 TEAEs
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 comes first.
Percentage of subjects with grade ≥ 3 TEAEs
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 comes first.
Number of subjects with 1 or more TEAEs leading to treatment discontinuation
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 comes first.
Percentage of subjects with 1 or more TEAEs leading to dose modification
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 comes first.
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation
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 comes first.
Number of subjects with 1 or more SAEs (serious adverse events)
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 comes first.
Percentage of subjects with 1 or more SAEs
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 comes first.
7 secondary outcomes
Serum Concentrations of CAN04 and Folfirnox
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 comes first.
Antidrug antibodies (ADAs) against CAN04
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 comes first.
Change in serum IL-6 (Interleukin-6) concentration
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 comes first.
Change in serum CRP (C-reactive protein) concentration
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 comes first.
Overall response rate (ORR)
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 comes first.
Progression free survival
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 comes first.
Overall Survival
Time frame: Up to 36 months after 1st dose of last subject (or death)
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 29 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Ignacio Garcia-Ribas, MD, PhD study director
Cantargia AB
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAN04 and FOLFIRINOX in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Cantargia AB at 9 sites in 2 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 15 inclusion and 24 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, France. 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 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.
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?
Frequency of TEAEs (Treatment-emergent adverse events) (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 comes first.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.