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    Summary
    EudraCT Number:2021-005873-25
    Sponsor's Protocol Code Number:SN201(CLAUDIO-01)
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-005873-25
    A.3Full title of the trial
    A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of SOT102 as a single drug or in combination with standard of care treatment, in patients with stomach and pancreas cancer
    A.4.1Sponsor's protocol code numberSN201(CLAUDIO-01)
    A.5.4Other Identifiers
    Name:IND NumberNumber: 157062
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSOTIO Biotech a.s.
    B.1.3.4CountryCzechia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSOTIO Biotech a.s.
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOTIO Biotech a.s.
    B.5.2Functional name of contact pointClinical Trial SOTIO
    B.5.3 Address:
    B.5.3.1Street AddressJankovcova 1518/2
    B.5.3.2Town/ cityPrague 7
    B.5.3.3Post code170 00
    B.5.3.4CountryCzechia
    B.5.6E-mailclinicaltrial@sotio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSOT102
    D.3.2Product code SOT102
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNantibody-drug conjugate of an anti-CLDN18.2 mAb and the cytotoxic drug PNU159682, coupled by a Gly2-EDA linker
    D.3.9.2Current sponsor codeSOT102
    D.3.9.3Other descriptive nameSOT102
    D.3.9.4EV Substance CodeSUB253422
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product type– antibody-drug conjugate
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastric and pancreatic adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Stomach and pancreas cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10051971
    E.1.2Term Pancreatic adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A and Part B
    To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line SoC treatment. MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT) evaluable patients experiencing a DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.
    Part C and Part D
    To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by objective response rate
    E.2.2Secondary objectives of the trial
    Part A and Part B
    To assess the safety and tolerability of SOT102 in monotherapy and in combination with first-line SoC treatment by the occurrence of DLTs, and treatment-emergent AEs (TEAEs), SOT102-related AEs, serious AEs, AEs leading to premature discont of SOT102, deaths, or abnormal clinical laboratory test. The pharmacokinetics (PK) of total SOT102, conjug SOT102, PNU159682, PNU-ethylene diamine (EDA), PNU-EDA-GGT (M4), PNU-EDA-GG (M5), and PNU-EDA-G (M6)
    Part C and Part D
    To evaluate measures of efficacy safety and tolerability of SOT102 in monotherapy and in combination with first-line SoC treatment by duration of response, progression-free survival per RECIST 1.1 clinical benefit rate per RECIST 1.1 (Part C only), overall survival. The occurrence of TEAEs, SOT102-related AEs, SAEs, AEs leading to premature disc of SOT102, deaths, or abormal clinical lab test The PK of tot SOT102, conjug SOT102, PNU159682, PNU-EDA, PNU-EDA-GGT (M4), PNU-EDA-GG (M5), and PNU-EDA-G(M6
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria applicable to all trial parts
    Age ≥18 years
    Written informed consent given prior to any trial-specific procedures
    Adequate organ function as assessed by the following parameters: hematologic; hepatic; renal; prothrombin time/international normalized ratio (INR); albumin; proteinuria.Serum concentrations of potassium, magnesium, and calcium within normal range
    Eastern Cooperative Oncology Group (ECOG) performance status ≤1
    Estimated life expectancy ≥3 months as per investigator’s assessment
    A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
    Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
    A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 9 months after the last dose of SOT-102 or first-line SoC treatment (whichever occurs later)
    Male patients must agree to use a condom during treatment and for 9 months after SOT102 or first-line SoC treatment discontinuation. Male pat wishing to become a father during or after the trial should consider sperm preservation. WOCBP partner of male part should use highly effective contrac methods for 9 months after SOT102 or first-line SoC treat disc
    Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography or nuclear medicine methodology (multiple gated acquisition scanning [MUGA])
    QTcF interval <450 msec on screening electrocardiogram (ECG)
    Patient is, in the judgement of the investigator, an appropriate candidate for experimental therapy
    Patient agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period)
    All previous cancer therapies for locally advanced gastric/pancreatic cancer and any agents that have not received regulatory approval for any indication must have been discontinued prior to day 1 of cycle 1.
    Part A
    Adequate tumor tissue or cytology sample or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
    Patient has advanced inoperable or metastatic disease
    Patient has received and/or has been determined to be intolerant of all standard of care therapy known to confer clinical benefit
    Measurable or non-measurable disease according to RECIST 1.1
    Histological or cytological evidence of adenocarcinoma of the stomach or GEJ or pancreas that is advanced or metastatic
    PartB
    Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
    Patient has advanced inoperable or metastatic disease
    Patient must have at least one measurable lesion according to RECIST 1.1
    Patients with gastric/GEJ adenocarcinoma (gastric B)
    Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
    Must have HER2-negative tumors
    Patients with pancreatic adenocarcinoma (pancreatic B)
    Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
    PartC
    Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method.
    Patient has advanced inoperable or metastatic disease
    Measurable disease according to RECIST 1.1.
    Patients with gastric/GEJ adenocarcinoma (gastric C)
    Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
    Must have received at least two prior systemic therapies for advanced or metastatic disease.
    Patients with pancreatic adenocarcinoma (pancreatic C)
    Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
    Must have received at least one prior systemic therapy for advanced or metastatic disease If HER2 overexpression: must have received anti-HER2 therapy.
    Part D
    Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method.
    Patient must have at least one measurable lesion according to RECIST 1.1. At least one measurable lesion must be outside of an earlier radiation field or must have progressed after radiation therapy.
    Patients with gastric/GEJ adenocarcinoma (gastric D)
    Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced inoperable or metastatic
    Must have HER2-negative tumors
    Patients with pancreatic adenocarcinoma (pancreatic D)
    Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic
    E.4Principal exclusion criteria
    Prior therapy with any agent directed at CLDN18.2
    Patient has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects
    Patient has been previously treated with the maximum cumulative dose of anthracyclines
    Severe preexisting medical conditions as per judgement of the investigator
    History of interstitial pneumonitis or pulmonary fibrosis
    Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days.
    Patient has peripheral sensory neuropathy grade ≥2
    Active infection requiring systemic therapy that is not clinically controlled before the signature of the ICF
    Patients with HIV will be eligible if
    •CD4+ T-cell (CD4+) counts ≥350 cells/uL
    •they have no history of AIDS-defining opportunistic infections
    •they are not currently on HIV therapy
    Patients with hepatitis B will be eligible if:
    •there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and anti-HBc–positive
    Patients with hepatitis C will be eligible if:
    •they have completed curative antiviral treatment and have HCV viral load below the limit of quantification
    Alcohol or drug abuse as determined by the investigator
    Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the patient is able to comply with trial requirements
    New York Heart Association class ≥3 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1
    History of major ventricular arrhythmias
    History or family history of congenital long QT syndrome
    Bradycardia (<50 beats per minute)
    Family history of sudden cardiac death before age 50
    Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention
    Hypersensitivity or intolerance to any component of trial intervention
    Vaccination with a live or live-attenuated vaccine within 30 days prior the first dose of trial interventions
    Part A Part C
    Any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
    Part B
    General. Patients must not have received any systemic therapy for metastatic desease. Patients must not have received any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
    Patients with contraindications to any component of the first-line SoC treatment
    Patients with clinically active inflammatory bowel disease
    Patients with gastric/GEJ adenocarcinoma (gastric B):
    Dihydropyrimidine dehydrogenase (DPD) deficiency
    Patient has been treated with immunosuppressive medications ≤14 days prior to day 1 of cycle 1.
    Concomitant use of drugs known to prolong the QT/QTc interval
    Patients with pancreatic adenocarcinoma (pancreatic B)
    Patients more clinically suitable (e.g., with BRCA1/2 mutation) to receive treatment with leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) as compared to nab-paclitaxel and gemcitabine according to the investigator’s opinion
    Part D
    Patients must not have received any systemic therapy for metastatic disease.Patients must not have received any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer. Exception: stable disease under hormonal treatment for prostate cancer, stable disease under hormonal treatment for breast cancer
    Patients with contraindications to any component of the first-line SoC treatment
    Patients with clinically active inflammatory bowel disease
    Patients with gastric/GEJ adenocarcinoma (gastric D) only:
    DPD deficiency
    Patient has been treated with immunosuppressive medications ≤14 days prior to day 1 of cycle 1
    Concomitant use of drugs known to prolong the QT/QTc interval
    Patients with pancreatic adenocarcinoma (pancreatic D)
    Patients more clinically suitable (e.g., with BRCA1/2 mutation) to receive treatment with FOLFIRINOX as compared to nab-paclitaxel and gemcitabine according to the investigator’s opinion
    E.5 End points
    E.5.1Primary end point(s)
    Part A-B :MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.
    Part C (SOT102 monotherapy, cohort expansion)
    Objective response rate (ORR)
    Part D (SOT102 combined with first-line SoC treatment, cohort expansion)
    ORR
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    The occurrence of DLTs, occurrence of treatment-emergent AEs (TEAEs), SOT102- related AEs, serious AEs (SAEs), AEs leading to premature discontinuation of SOT102, deaths, or clinical laboratory test abnormalities
    • PK of total SOT102, conjugated SOT102, PNU159682, PNU-EDA, -EDA-GGT (M4), PNU-EDA-GG (M5), and PNU-EDA-G (M6)
    • Anecdotal tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by type and CLDN18.2 expression. The number of patients with detected antibodies against any part of SOT102
    Additionally for PartC & Part D
    Assessment of global and disease-specific QoL by patient-reported questionnaires EORTC
    QLQ-C30 and EORTC QLQ-STO22 for patients with gastric cancer, and EORTC QLQC30
    and EORTC QLQ-PAN26 for patients with pancreatic cancer
    Part D in additon:
    DoR and PFS per RECIST 1.1, OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Bifurcated: Part A and Part B, and their respective expansions
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Spain
    Czechia
    Belgium
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS including follow-up calls.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 176
    F.4.2.2In the whole clinical trial 269
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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