A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

NCT04990037 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CAN04CLIN003
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Carcinoma; Adenocarcinoma; Pancreatic Cancer; Metastatic

Outcome Measures

Primary Outcomes (10)

• Frequency of TEAEs (Treatment-emergent adverse events)

  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)

  Up to day 28

• Number of subjects with 1 or more TEAEs leading to dose modifications

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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

  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)

  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.

Study Arms (1)

CAN04 and FOLFIRINOX

EXPERIMENTAL

Subjects will receive bi-weekly doses of CAN04 in combination with FOLFIRINOX given as standard regimen.

Drug: CAN04; Drug: FOLFIRINOX

Interventions

CAN04 DRUG

Administered intravenously

Also known as: Nadunolimab

CAN04 and FOLFIRINOX

FOLFIRINOX DRUG

Administered intravenously

CAN04 and FOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Cantargia AB: lead

Study Sites (9)

EDOG - Institut Bergonie - PPDS

Bordeaux, 33000, France

Location

EDOG Institut de Cancerologie de l'Ouest - PPDS

Nantes, 44100, France

Location

EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

Rennes, France

Location

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

Barcelona, 08035, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

START MADRID_Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Carcinoma; Adenocarcinoma; Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ignacio Garcia-Ribas, MD, PhD

  Cantargia AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: August 4, 2021
• Study Start: July 19, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 15, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); ES (5)