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    Summary
    EudraCT Number:2021-003406-47
    Sponsor's Protocol Code Number:FS118-21201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-25
    Trial results View 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-003406-47
    A.3Full title of the trial
    A Phase 2 Open-Label Basket Study of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Subjects with Advanced and Early-Stage Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FS118 Phase 2 Study in Patients with Advanced Malignancies
    A.4.1Sponsor's protocol code numberFS118-21201
    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 SponsorinvoX Pharma Limited
    B.1.3.4CountryUnited Kingdom
    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 supportinvoX Pharma Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinvoX Pharma Limited
    B.5.2Functional name of contact pointinvoX Pharma Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressSuite 2, First Floor, The Westworks, White City Place
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 7FQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44203 786 5144
    B.5.6E-mailabhay.patki@invoxpharma.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 nameFS118
    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 INNNone
    D.3.9.2Current sponsor codeFS118
    D.3.9.4EV Substance CodeSUB234630
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 No
    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 No
    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
    Advanced and early-stage malignancies
    E.1.1.1Medical condition in easily understood language
    Severe malignancies
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    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
    Cohort A (NSCLC ): To assess the efficacy of FS118 in terms of radiological response in all subjects;
    Cohort B (NSCLC WOO): To evaluate changes in specific T cell density (cells/mm2) in tumour samples collected pre- and post-treatment with FS118.
    Cohort C (DLBCL): To assess the efficacy of FS118 in terms of radiological response.
    E.2.2Secondary objectives of the trial
    Cohort A (NSCLC ): To assess the efficacy of FS118 in all subjects by alternative endpoints; To assess PK parameters for FS118; Assessment of the safety and tolerability of FS118;
    Cohort B (NSCLC WOO): Assessment of MPR to pre-operative FS118 therapy in resected tumour and lymph nodes; Assessment of radiographic response to pre-operative FS118 therapy; To assess the safety and tolerability of FS118 given in a pre-operative setting; To assess PK parameters for FS118; To evaluate soluble receptors (LAG-3 and PD-L1) following pre-operative FS118 therapy;
    Cohort C (DLBCL): To assess the efficacy of FS118 in all subjects by alternative endpoints; To assess PK parameters for FS118; Assessment of the safety and tolerability of FS118.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Core Inclusion Criteria:
    1.The subject provides written informed consent for the trial.
    2.≥18 years of age on the day of signing the informed consent.
    3.Have an ECOG performance status of 0 to 1.
    4.Have a life expectancy of at least 3 months.

    Cohort A (NSCLC):
    In addition to the core inclusion criteria, each subject in Cohort A must also meet the following inclusion criteria to be enrolled:
    5.Histological or cytological diagnosis of NSCLC.
    6.Tumour negative for EGFR mutation and ALK translocation.
    7.One prior line of a platinum-doublet regimen that was given for at least 2 cycles and that did not contain a PD-(L)1 or any other health authority approved or experimental immune modulating agent.
    8.Have measurable disease per RECIST v1.1.

    Cohort B (NSCLC WOO): In addition to the core inclusion criteria, each subject in Part B must meet the following inclusion criteria:
    9.Histological or cytological diagnosis of NSCLC.
    10.Tumour negative for EGFR mutation and ALK translocation.
    11.Subjects must have adequate lung function to permit surgical resection.
    12.At least 1 measurable lesion as per RECIST v1.1.

    Cohort C (DLBCL):
    In addition to the core inclusion criteria, each subject must meet the following inclusion criteria:
    13.Histologically confirmed diagnosis of DLBCL with relapsed and/or refractory disease.
    14.Received at least two systemic regimens for the treatment of DLBCL. One therapy line must have included a CD20-targeted therapy and one therapy line must have included CAR-T cell therapy where this is the institution´s standard of care, unless contraindicated.
    15.At least one bi-dimensionally, PET positive, measurable disease site by spiral CT scan defined as a lesion that measures at least ≥15 mm in the LD and ≥10 mm in the SAD at baseline as defined by Lugano classification.

    For further information, please refer to the clinical protocol.
    E.4Principal exclusion criteria
    Core Exclusion Criteria
    Subjects are excluded from the study if any of the following criteria apply:
    1.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
    2.Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to treatment.
    3.Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease.
    4.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    5.Has known active CNS metastases and/or carcinomatous meningitis.
    6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
    7. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
    8. Has a history of prior severe or life-threatening infusion related reaction or skin adverse reaction related to previous treatment with other immune stimulatory anticancer agents.

    Exclusion Criteria Cohort A (NSCLC):
    8. Receipt of greater than 1 line of treatment with chemotherapy for Stage IIIB/IIIC/IV disease.
    9. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment.

    Exclusion Criteria Cohort B (NSCLC WOO):
    10. Administration of chemotherapy or any other anti-cancer therapy (including radiotherapy) in the pre-operative period.

    Exclusion Criteria Cohort C: DLBCL:
    11.Known history of “double or triple hit” genetics or cytogenetic abnormalities involving chromosomal rearrangements of c-MYC, BCL-2 and BCL-6 genes.
    12.Subjects that have undergone ASCT within the period ≤3 months prior to signing the ICF.
    13.Subjects that have received an infusion of CAR T cells within 60 days prior to the planned date of dosing with FS118.

    For further information, please refer to the clinical protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A
    Efficacy Endpoints: Overall response rate (ORR) as per RECIST v1.1.

    Cohort B
    Biomarker/Pharmacodynamic Markers Endopoints: Change in tumour infiltrating T cells subtypes in response to FS118.

    Cohort C
    Efficacy Endpoints: ORR as per the Lugano Classification.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study duration at the study visits.
    E.5.2Secondary end point(s)
    Cohort A

    Efficacy Endpoints:
    •Assessments of antitumor activity include DCR, DoR, DoC, and PFS/iPFS as assessed by RECIST v1.1 and iRECIST.
    •OS.

    PK Endpoints:
    •PK endpoints include, but are not limited to the following parameters: Cycle 1: Cmax, Tmax, Ctrough, AUC, T1/2, AUC0- τ, Cavg (= AUC0-τ/τ), CL, Vd, and Rac for AUC0-τ.
    •Cycle 2 onwards: Cmax, Tmax, Ctrough.

    Safety Endpoints:
    •Incidence, severity, and duration of AEs as defined by CTCAE v5.0.

    Cohort B

    Efficacy Endpoints:
    •MPR defined as <10% residual viable tumour cells in the resection specimen.
    •ORR assessed as per RECIST v1.1.

    Safety Endpoints:
    •The number of subjects with Grade 2, 3 and 4 laboratory abnormalities, as defined by CTCAE v5.0.
    •The number of Grade 2, 3 and 4 AEs that occur while a subject is participating in the study, as defined by CTCAE v5.0.

    PK Endpoints:
    PK endpoints include, but are not limited to the following parameters:
    •Cycle 1: Cmax, Tmax, Ctrough, AUC, T1/2, AUC0- τ, Cavg (= AUC0-τ/τ), CL, Vd, and Rac for AUC0-τ.

    Biomarker/Pharmacology/Pharmacodynamic Endpoints: Fold induction of sLAG-3 and sPD-L1.


    Cohort C

    Efficacy Endpoints:
    •Assessments of antitumor activity include DCR, DoR, DoC, and PFS as assessed by the Revised Response Criteria for Malignant Lymphoma.
    •OS.

    PK Endpoints:
    •PK endpoints include, but are not limited to the following parameters: Cycle 1: Cmax, Tmax, Ctrough, AUC, T1/2, AUC0-τ, Cavg (= AUC0-τ/τ), CL, Vd, and Rac for AUC0-τ.
    •Cycle 2 onwards: Cmax, Tmax, Ctrough.

    Safety Endpoints: Incidence, severity, and duration of AEs as defined by CTCAE v5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study duration.
    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 Yes
    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) No
    E.7.1.1First administration to humans No
    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 No
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Moldova, Republic of
    Ukraine
    Bulgaria
    France
    Georgia
    India
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study is defined as the date on which the last subject
    completes the last visit (includes Follow-up visit).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 94
    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)
    Continued access. Subjects may continue with the treatment if there is benefic, upto 104 administrations (A&C) or 4/2 administrations (B).
    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 Decision2023-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-11-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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