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    Summary
    EudraCT Number:2020-005990-29
    Sponsor's Protocol Code Number:ENGOT-OV64/NSGO-CTU-SOLERO
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-12-06
    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 ConcernedNorway - NOMA
    A.2EudraCT number2020-005990-29
    A.3Full title of the trial
    An Early Phase Randomized Trial of APX005M in BRCAwt Patients with Recurrent Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapy and radiation therapy in combination with chemotherapy in relapsed ovarian cancer.
    A.4.1Sponsor's protocol code numberENGOT-OV64/NSGO-CTU-SOLERO
    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 SponsorNordic Society of Gynaecological Oncology - Clinical Trial Unit (NSGO-CTU)
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportApexigen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNSGO-CTU
    B.5.2Functional name of contact pointPernille Haun Albrechtsen
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Oncology 9431, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535453389
    B.5.6E-mailpernille.haun.albrechtsen@regionh.dk
    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.3.2Product code APX005M
    D.3.4Pharmaceutical form Solution for injection
    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 INNNot yet established
    D.3.9.1CAS number 2305607-45-6
    D.3.9.2Current sponsor codeAPX005M
    D.3.9.3Other descriptive nameAPX005-01
    D.3.9.4EV Substance CodeSUB197803
    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 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) Yes
    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 typeHumanized immunoglobuline monoclonal antibody
    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
    Patients with histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer with radiologically or histologically confirmation of relapsed disease, and with known BRCA wildtype. Platinum combination therapy must be an option.
    E.1.1.1Medical condition in easily understood language
    Patients with relapsed ovarian cancer where platinum combination therapy is an option
    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 PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10080244
    E.1.2Term Peritoneal cancer index
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the preliminary efficacy of APX005M-carboplatin-PLD and APX005M-radiotherapy-carboplatin-PLD combinations by overall response rate (ORR) at 12 weeks
    E.2.2Secondary objectives of the trial
    - To evaluate the preliminary efficacy of APX005M-carboplatin-PLD and APX005M-radiotherapy-carboplatin-PLD combinations by overall response rate (ORR) at 24 weeks, progression-free survival (PFS), and disease control rate (DCR)
    - To evaluate safety
    - To evaluate Patient Reported Outcomes (PROs) in treatment arms
    Exploratory/Translational research:
    - To describe genetic, molecular and immunological mechanisms in blood and tumor
    - To explore the efficacy of APX005M in combination in the molecular and immunological subgroups
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation.
    2. Histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.
    3. Radiological or histological confirmation of relapse disease ≥ 6 month after last chemotherapy.
    4. Known BRCAwt.
    5. Have completed at least one line of platinum-containing chemotherapy (maximum 3 previous lines of therapy are permitted). Earlier PARPi and earlier bevacizumab therapies are permitted.
    6. Must have measurable or evaluable disease according to RECIST 1.1.
    7. Baseline biopsy: Tissue biopsy for submission to central laboratory prior to study treatment should be from a newly obtained metastatic biopsy, if there is a lesion suitable for biopsy and the subject consents to this procedure. If a metastatic biopsy is not feasible, or patient is unwilling to provide new biopsy, archival tissue samples should be submitted. Archival tissue sample from metastatic site is preferred; however, archival tissue sample of primary tumor is acceptable.
    8. Must consent to undergo mandatory tumor biopsy of at least one metastatic site at day 84 (±7). Biopsy at day 84 (±7) is only applicable if surgery is not performed.
    9. Age ≥ 18 years.
    10. Body weight > 30 kg.
    11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    12. Must have a life expectancy ≥ 12 weeks.
    13. Must have normal Left Ventricular Ejection Fraction (LVEF > 50%) measured by MUGA scan or echocardiography.
    14. Must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below (5% deviation for hematological parameters and 10% deviation for biochemistry is permitted):
    a. Haemoglobin ≥ 10.0 g/dL (≥ 6.2 mmol/L) with no blood transfusion in the past 28 days;
    b. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
    c. Platelet count ≥ 100 x 10^9/L;
    d. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN);
    e. Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) /Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case, they must be ≤ 5 x ULN.
    15. Must have creatinine clearance estimated ≥ 50 mL/min using the Cockcroft-Gault formula.
    16. A participant is eligible to participate, if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
    - Is not a woman of childbearing potential (WOCBP) OR
    - Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 of the protocol during the intervention period and for at least 90 days after the last dose of APX005M and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) prior to the first dose of study intervention.
    - A WOCBP must have a negative urine or serum pregnancy test within 28 days of study treatment and a confirmed negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention.
    E.4Principal exclusion criteria
    1. Previous immunotherapy (for example anti-PD-1/L1).2. Other malignancy unless curatively treated with no evidence of disease for ≥ 3years,except adequately treated non-melanoma skin cancer,curatively treated in situ cancer of the cervix,ductal carcinoma in situ (DCIS) and stage 1 grade 1 endometrial carcinoma.3. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia,uncontrolled symptomatic arrhythmia,congestive heart failure,QTcF prolongation >500 ms,electrolyte disturbances, etc.),or subjects with congenital long QT syndrome.4. Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.5. Subjects with symptomatic uncontrolled brain metastases.A scan to confirm the absence of brain metastases is not required.Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.6. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.Subjects who have received acute,low-dose,systemic immunosuppressant medications (e.g.,a one-time dose of dexamethasone for nausea) or physiologic replacement doses (i.e. prednisone 5 - 7.5 mg/day) for adrenal insufficiency may be enrolled in the study.Inhaled or topical steroids,and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent,are permitted in the absence of active autoimmune disease.7. Prior radiation therapy.8. Planned concomitant therapy with any other anticancer therapy.9. Conditions requiring ongoing therapy with antibiotics.10. History of any arterial thromboembolic event within 3 months prior to first dose of APX005M.11. Active coagulopathy.12. Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation.13. History of organ transplant.14. Major surgery or significant traumatic injury within 4 weeks prior to first dose of study drugs.15. Pregnant or breastfeeding women.16. Subjects with a known hypersensitivity to any of the excipients of the product.17. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy,except alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.a. Subjects with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Lead Principal Investigator (PI) of the respective collaborative group.b. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with study drugs may be included only after consultation with the Lead PI of the respective collaborative group.18. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease,diverticulitis,systemic lupus erythematosus,Sarcoidosis syndrome,or Wegener syndrome.The following are exceptions to this criterion:
    a. Subjects with vitiligo or alopecia.b. Subjects with hypothyroidism stable on hormone replacement.c. Any chronic skin condition that does not require systemic therapy.d. Subjects without active disease in the last 5 years may be included,but only after consultation with the Lead PI of the respective collaborative group.e. Subjects with celiac disease controlled by diet alone.19. Subjects considered a poor medical risk due to a serious,uncontrolled medical disorder,non-malignant systemic disease or active,uncontrolled infection.Examples include,but are not limited to,uncontrolled symptomatic congestive heart failure, uncontrolled hypertension,unstable angina pectoris,cardiac arrhythmia,recent (within 3 months),uncontrolled major seizure disorder,serious chronic gastrointestinal conditions associated with diarrhea,interstitial lung disease or any psychiatric disorder/social situations that would limit compliance with study requirement,substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.20. Immunocompromised subjects,e.g. subjects who are known to be serologically positive
    for human immunodeficiency virus (HIV).21. Active infection including tuberculosis, hepatitis B, hepatitis C.Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.22. Receipt of live attenuated vaccine within 30 days prior to the first dose of Investigational Product (IP). Note: Subjects, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. COVID-19 vaccination must be performed minimum 7 days prior to first dose of APX005M.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) at 12 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    1. ORR at 24 weeks
    2. Progression-free survival (PFS)
    3. Disease control rate (DCR)
    4. Adverse Events until 30 days after last dose of study drug(s)
    5. Patient Reported Outcomes (PROs) by EORTC QLQ C30 and OV28 overall measures and single items at baseline and every 12 weeks
    6. Changes in molecular and immunological markers of response and/or resistance over time
    7. Changes in molecular and immunological markers and efficacy and/or resistance to treatment in defined subgroups
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 24 weeks
    2. 24 months
    3. 12 weeks and 24 weeks
    4. 30 days after last dose
    5. 24 months
    6. 24 weeks
    7. 24 weeks
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Radiotherapy-carboplatin-PLD
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Belgium
    Czechia
    Denmark
    Finland
    Norway
    Switzerland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 90
    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)
    Patients will be treated at the discretion of the treating physician as per standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation BGOG
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation CEEGOG
    G.4.3.4Network Country Czechia
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation SWISS-GO
    G.4.3.4Network Country Switzerland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-10-28
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