A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors

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Brief Title

A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors

Official Title

A Phase 1 / 2 Study of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumours

Brief Summary

      This is a Phase 1/2, open-label, multicentric, non-randomised, parallel-arm study that aims
      to establish the safety, tolerability, and initial efficacy of CAN04 in combination with 3
      SoC chemotherapies (mFOLFOX, DTX, and G/C).
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

To assess the safety and tolerability of CAN04 in combination with selected standard hemotherapy regimens and to establish MTD and/or RP2D.

Secondary Outcome

 To assess preliminary anti-tumour activity of CAN04 in combination with selected standard chemotherapy regimens.

Condition

Advanced Solid Tumors

Intervention

CAN04 (nadunolimab)

Study Arms / Comparison Groups

 CAN04 and chemotherapy (mFOLFOX)
Description:  12 cycles for mFOLFOX/CAN04-Each cycle is 2 weeks.mFOLFOX/CAN04 treatment arm: CAN04 and mFOLFOX are administered on Day 1 with a mFOLFOX continuation of regime on Day 2. CAN04 is only administered on Day 1.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

180

Start Date

September 22, 2021

Completion Date

September 6, 2024

Primary Completion Date

September 8, 2023

Eligibility Criteria

        Inclusion Criteria:

        PHASE 1 and PHASE 2:

          -  Subject must be able to understand and sign written informed consent, according to
             local guidelines.

          -  Subject must be ≥18 years of age at the time of signature of the ICF.

          -  Subject must have an ECOG PS score of 0 or 1.

          -  Subject must have adequate organ function, as indicated by the laboratory values in
             the protocol

          -  Women of childbearing potential must have a negative serum pregnancy test before study
             entry. Women of non-childbearing potential will have had at least 24 continuous months
             of natural (spontaneous) amenorrhea, and an appropriate clinical profile (eg, age
             appropriate, history of vasomotor symptoms), or have had hysterectomy, bilateral
             salpingectomy or bilateral oophorectomy>6 weeks before screening.

          -  Male or female subjects: Male subjects with female partners of childbearing potential
             and female subjects of childbearing potential are required to use 2 forms of
             acceptable contraception, including 1 barrier method, during their participation in
             the study and for 4 months after the last dose of CAN04 or for 6 months after the last
             dose of the relevant chemotherapies, whatever is longer. Male subjects must also
             refrain from donating sperm during their participation in the study and in the period
             when contraceptives are required

          -  Subjects must not have contraindications according to the approved local summary of
             product characteristics (SmPC) for the respective components of the SoC
             chemotherapies.

        PHASE 1 (Dose Escalation)

          -  Subject has histologically or cytologically confirmed diagnosis of locally advanced
             cancer or metastatic cancer. Subjects do not need to have measurable disease per
             response evaluation criteria in solid tumours (RECIST) v1.1.

          -  Subject has a condition where all standard therapeutic options with proven survival
             benefit have been exhausted, refused by the subject, or are contraindicated. OR
             Subject has a condition where 1 of the 3 study regimens (mFOLFOX, DTX, or G/C) is
             considered SoC for the next-line treatment.

          -  Subject has additional disease characteristics per treatment arm:

               -  mFOLFOX Arm: All subjects eligible for mFOLFOX can be enrolled. A maximum of 2
                  previous lines of cytotoxic chemotherapy treatment for metastatic disease is
                  allowed (targeted agents without cytotoxic effect will not be counted).

               -  DTX Arm: Subjects eligible to receive DTX as monotherapy for NSCLC can be
                  enrolled in this treatment arm. No more than 2 lines of prior systemic
                  anti-cancer therapies for the metastatic disease are allowed. Targeted therapy is
                  not counted as prior therapy. Subjects who received DTX monotherapy in a prior
                  line of therapy are not eligible.

               -  G/C Arm: All subjects eligible for G/C can be enrolled (including first-line
                  treatments).. Subjects with BTC will be prioritized.

        PHASE 2 All treatment arms in Phase 2 (CRC, NSCLC or BTC)

          -  Subject must have at least 1 measurable lesion as defined by RECIST v1.1. Tumour
             lesions that have been irradiated ≥4 weeks before the start of treatment, and have
             subsequently had documented progression, may be chosen as target lesions in the
             absence of measurable lesions that have not been irradiated.

          -  Only applicable after the second interim analysis has been performed: Primary or
             metastatic lesion amenable to biopsy and willingness of the subject to undergo a
             screening (if no adequate archival tissue is available) and an on-treatment biopsy (as
             defined in the protocol). The lesion accessible for biopsy may not be the only target
             lesion and should not be located in a previously irradiated field (unless this index
             lesion has PD ≥20% after radiation). The requirement(s) for the screening and/or
             on-treatment biopsy and/or archival tissue may be waived by the sponsor for individual
             sites and subjects, in particular if tumour locations are not safely accessible, after
             discussion and documented agreement between the site and the sponsor´s medical
             monitor.

        CRC Arm

          -  Subject has definitive histologically or cytologically confirmed metastatic or locally
             advanced adenocarcinoma of the colon or rectum without possibility of locoregional
             treatment with curative intention or candidate for curative metastasectomy

          -  Subject has received at least 2 prior lines of therapy for non-resectable locally
             advanced or metastatic CRC and has progressed or is intolerant to those therapies. If
             the tumour is microsatellite instability-high, it should have progressed on a previous
             immune CPI unless contraindicated, or such therapy is not available to the subject.
             Subjects with KRAS wildtype should be eligible to receive mFOLFOX and should have
             received anti-EGFR therapy unless contraindicated or not available for the subject.

          -  Note: For subjects who received adjuvant or neoadjuvant chemotherapy and had
             recurrence within 6 months of completion of the adjuvant or neoadjuvant chemotherapy,
             the adjuvant or neoadjuvant therapy is counted as the first line of chemotherapy for
             the metastatic disease.

        NSCLC Arm

          -  Subject has histologically or cytologically confirmed squamous or non-squamous NSCLC
             unresectable stage IIIB/C or stage IV for whom monotherapy DTX treatment is indicated.

          -  Subject received platinum-based therapy and a programmed cell death protein 1 or
             programmed death-ligand 1 inhibitor as prior treatment regimens (unless
             contraindicated or such therapy is not available to the subject). Prior CPIs and
             chemotherapy may have been administered alone or in combination. No more than 2 prior
             lines of cytotoxic chemotherapy containing regimens for the advanced or metastatic
             disease are allowed.

        Note: Subjects who received DTX monotherapy in a prior line of therapy are not eligible.

          -  Subjects who received adjuvant or neoadjuvant chemotherapy and had recurrence within 6
             months of completion of the adjuvant or neoadjuvant chemotherapy are allowed to count
             the adjuvant or neoadjuvant therapy as the first line of chemotherapy for the
             recurrent/metastatic disease.

          -  Subject eligible for mutation-targeted therapies (eg, osimertinib, alectinib,
             crizotinib, larotrectinib, capmatinib, pralsetinib) must have exhausted treatment
             options for targeted therapies available locally

        BTC Arm

          -  Subject has histopathological or cytological biliary tract carcinoma (intrahepatic or
             extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma)
             non-resectable, recurrent, or metastatic amenable for G/C treatment indicated as SoC.

          -  Subject has not received standard systemic anti-cancer therapies neither for
             non-resectable locally advanced nor for metastatic disease.

          -  Note: Subjects who received adjuvant or neoadjuvant chemotherapy and had recurrence
             within 6 months after completion of the adjuvant or neoadjuvant chemotherapy are
             eligible for the study.

        Exclusion Criteria:

          -  Subject has a known or suspected allergy to study drugs (including chemotherapy
             regimens), any of its components.

          -  Subject has another histologically confirmed cancer different from those described in
             inclusion criteria, except for cervical carcinoma in situ, superficial non-invasive
             bladder tumour, curatively treated stage I non-melanoma skin cancer, or prostate
             cancer subjects curatively treated with surgery or radiation and not receiving
             systemic or androgen deprivation therapy. Subjects with a history of another cancer,
             different from that described in the inclusion criteria, can be enrolled if the cancer
             was curatively treated ≥5 years ago and non-recurrence has been documented in the past
             2 years.

          -  Subject has uncontrolled or significant heart failure defined as New York Heart
             Association Classification III or IV.

          -  Subjects to receive mFOLFOX or DTX: having peripheral sensory neuropathy Grade ≥2.

          -  Subject has QT interval corrected using Fridericia's formula (QTcF) >480 msec at
             screening.

          -  Subjects to receive DTX and CAN04: if they have liver metastases and aspartate
             aminotransferase (AST) and/or ALT >1.5 × upper limit of normal (ULN) concomitant with
             alkaline phosphatase >2.5 × ULN.

          -  Subject has uncontrolled brain metastases. Subjects are allowed to be enrolled if
             brain metastasis has been previously treated with surgery, and/or stereotactic
             radiosurgery and are considered controlled (controlled by the dose ≤10 mg/day of
             prednisone or equivalent) at the time of the first dose of CAN04. For asymptomatic
             subjects, without known brain metastases, brain imaging during screening is not
             required. Subjects with known brain metastases should have undergone brain imaging in
             the frame of the imaging screening procedures.

          -  Subject has 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 can be enrolled when antibiotic
             treatment is complete and if there are no signs of residual infection. Note: Subjects
             with BTC who required stent placement should have the procedure completed 2 weeks
             before and be free of antibiotics (oral or parenteral) for at least 1 week before
             first treatment administration.

          -  Subject has a history of a relevant autoimmune disease as per assessment of the
             investigator or autoimmune disease requiring systemic immunosuppressive therapy (daily
             prednisone equivalent doses >10 mg/day).

          -  Subject is expected to require any other form of systemic or localised anti-neoplastic
             therapy while on study (including maintenance therapy with another agent, radiation
             therapy, and/or surgical resection).

          -  Subject has had an allogeneic tissue/solid organ transplant.

          -  Subject received a live vaccination, etanercept, or other tumour necrosis factor-alpha
             inhibitors prior to (within 28 days of first study drug administration) participation
             in this study. For severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
             vaccines, a wash-out of 2 weeks before first administration of study drug is
             recommended.

          -  Subject had treatment with systemic anti-cancer treatments, or major surgery within 4
             weeks before the first dose of study drug or 5 half-lives, whichever is shorter.
             Subjects should have recovered from previous treatment toxicity to Grade 1, baseline
             (except alopecia and peripheral neuropathy).

          -  Subject received radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for
             palliative irradiation to peripheral tumour lesions, other than for example spine or
             pelvis, without increased risk for delayed cytopenias) and has not recovered to Grade
             1 or better from related toxicity of such therapy (except for alopecia).

          -  Subject has 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 who test positive for human immunodeficiency virus (HIV) are NOT excluded
             from this study but must meet the following criteria:

               -  Have cluster of differentiation 4 (CD4)+ T-cell (CD4+) counts ≥350 cells/μL.

               -  Have not had an opportunistic infection within the past 12 months. Subjects on
                  prophylactic anti-microbials can be included in the study.

               -  Should be on established anti-retroviral therapy for at least 4 weeks.

               -  Have an HIV viral load less than 400 copies/mL before enrolment.

          -  Subject has a known history of any other relevant congenital or acquired
             immunodeficiency other than HIV infection.

          -  Subject has a history or current evidence of any condition, therapy, or laboratory
             abnormality that might confound the results of the study, interfere with the subject's
             participation for the full duration of the study, or is not in the best interest of
             the subject to participate, in the opinion of the treating investigator.

          -  Subject has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the study.

          -  Subject has any medical condition, co-morbidity, physical examination finding,
             metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the
             investigator, renders the subject unsuitable for participation in a clinical study due
             to high safety risks and/or potential to affect interpretation of results of the
             study.

          -  Subject has known allergy to any of the drugs or excipients in the allocated
             treatment.

          -  Only subjects in the G/C arm: Subjects who, as per applicable local label, due to
             hearing impairment or ongoing phenytoin administration, have contraindication for
             cisplatin.

        mFOLFOX Arm/CRC Arm Exclusion Criteria

          -  Subjects with clinical laboratory test values at screening below the lower limit of
             normal for any of the following electrolytes: potassium, magnesium, corrected or
             ionised calcium.

               -  NOTE: Subjects achieving normal values for these electrolytes with supplements
                  during the screening period are allowed at the discretion of the investigator.
                  Serum chemistry documenting normal electrolyte values is required prior to each
                  dose of oxaliplatin.

          -  Subjects with congenital long QT syndrome or a history of ventricular arrhythmias,
             including bradyarrhythmia (<50 beats per minute).

          -  Subjects with existing uncompensated heart disease: myocardial ischaemia or early (up
             to 4 weeks) post-infarction status, congestive heart failure, left ventricular
             hypertrophy, cardiomyopathy, conduction disorder within 6 months before enrolment.

          -  Subjects with dihydropyrimidine dehydrogenase (DPD) deficiency or who have been
             treated within 4 weeks of first dose of study treatment with potent DPD inhibitors
             (eg, brivudine, sorivudine). Subjects who previously received 5-FU without toxicity
             that can be correlated with DPD deficiency do not need to be tested

          -  Subjects with pernicious anaemia or other anaemias due to vitamin B12 deficiency that
             cannot be corrected before the first dose of mFOLFOX.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ignacio Garcia-Ribas, MD, PhD, +46 46 2756260, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05116891

Organization ID

CAN04CLIN004


Responsible Party

Sponsor

Study Sponsor

Cantargia AB


Study Sponsor

Ignacio Garcia-Ribas, MD, PhD, Study Director, Cantargia AB


Verification Date

July 2022