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    Summary
    EudraCT Number:2018-003402-63
    Sponsor's Protocol Code Number:GCT1046-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003402-63
    A.3Full title of the trial
    First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors
    Primo studio sull’uomo, in aperto, con aumento progressivo della dose con coorti di espansione, volto a valutare la sicurezza di GEN1046 in soggetti con tumori solidi maligni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors
    Studio sulla sicurezza di GEN1046 in soggetti con tumori solidi maligni
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberGCT1046-01
    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 SponsorGENMAB A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.4Telephone number004533779678
    B.5.5Fax number00453377
    B.5.6E-mailclinicaltrials@genmab.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 nameDuoBody-PD-L1x4-1BB
    D.3.2Product code [GEN1046]
    D.3.4Pharmaceutical form Concentrate for 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 INNGEN1046 (DuoBody-PD-L1x4-1BB)
    D.3.9.1CAS number 2253937-12-9
    D.3.9.2Current sponsor codeDuoBody-PD-L1x4-1BB
    D.3.9.4EV Substance CodeSUB195353
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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
    Malignant solid tumors:
    Patients with relapsed or refractory, advanced and/or metastatic non-small cell lung cancer (NSCLC), endometrial carcinoma (EC), urothelial carcinoma (UC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), or cervical cancer who are not anymore candidates for or refuse standard therapy
    Tumore solido maligno
    Soggetti con carcinoma polmonare non a piccole cellule (NSCLC), carcinoma endometriale (EC), carcinoma uroteliale (UC), carcinoma mammario triplo negativo (TNBC), carcinoma a cellule squamose della testa e del collo (SCCHN) o carcinoma cervicale,recidivante o refrattario, avanzato e/o metastatico, i quali non sono più candidati alla terapia standard o l'hanno rifiutata.
    E.1.1.1Medical condition in easily understood language
    advanced and/or metastatic non-small cell lung cancer, endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, or cervical cancer
    carcinoma polmonare non a piccole cellule, c. endometriale, c. uroteliale, c. mammario triplo negativo, c. a cellule squamose della testa e del collo o c. cervicale, avanzato e/o metastatico
    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 10065143
    E.1.2Term Malignant solid tumour
    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
    For Dose Escalation (study part I, that is NOT conducted in Italy):
    - Determine the MTD and/or the recommended Phase 2 dose (RP2D)
    - Establish the safety profile of GEN1046

    For Dose Expansion (study part 2, that is conducted in Italy):
    - Establish the safety profile of GEN1046
    Per la parte di "aumento progressivo della dose" (parte I dello studio, che NON sarà svolta in Italia):
    - Determinare la dose massima tollerata (MTD) e/o la dose raccomandata per la fase 2 (RP2D)
    - Stabilire il profilo di sicurezza di GEN1046

    Per la parte di "espansione della dose" (parte 2 dello studio, che sarà svolta in Italia):
    • Stabilire il profilo di sicurezza di GEN1046
    E.2.2Secondary objectives of the trial
    - Establish the PK profile
    - Evaluate immunogenicity of GEN1046
    - Evaluate the anti-tumor activity of GEN1046
    • Stabilire il profilo PK
    • Valutare l’immunogenicità di GEN1046
    • Valutare l’attività antitumorale di GEN1046
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Dose Escalation (study part I, that is NOT conducted in Italy):
    • Measurable disease according to RECIST 1.1.
    • Eastern Cooperative Oncology Group (ECOG) 0-1.
    • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
    • Subjects must have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.

    For Dose Expansion (study part 2, that is conducted in Italy):
    • Measurable disease according to RECIST 1.1.
    • Eastern Cooperative Oncology Group (ECOG) 0-1.
    • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
    • Subjects must have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for or refuse standard therapy.
    Per la parte di "aumento progressivo della dose" (parte I dello studio, che NON sarà svolta in Italia):
    • Il soggetto deve presentare una malattia misurabile secondo RECIST 1.1
    • Il soggetto deve presentare un punteggio Eastern Cooperative Oncology Group (ECOG) di 0-1
    • Il soggetto deve presentare funzionie d'organo e di midollo osseo (funzione ematologica, stato di coagulazione, funzione epatica e funzione renale) come definite nel protocollo
    • I soggetti devono presentare un tumore solido non-SNC confermato istologicamente o citologicamente che sia metastatico o non resecabile e per i quali non esista una terapia standard disponibile in grado di conferire beneficio clinico, o soggetti che non siano candidati per tale terapia disponibile e per i quali, secondo il parere dello sperimentatore, la terapia sperimentale con GEN1046 può essere di aiuto.

    Per la parte di "espansione della dose" (parte 2 dello studio, che sarà svolta in Italia):
    • Il soggetto deve presentare una malattia misurabile secondo RECIST 1.1
    • Il soggetto deve presentare un punteggio Eastern Cooperative Oncology Group (ECOG) di 0-1
    • Il soggetto deve presentare funzionie d'organo e di midollo osseo (funzione ematologica, stato di coagulazione, funzione epatica e funzione renale) come definite nel protocollo
    • I soggetti devono presentare una diagnosi istologica o citologica di carcinoma polmonare non a piccole cellule (NSCLC) , carcinoma endometriale (EC), carcinoma uroteliale (UC), carcinoma mammario triplo negativo (TNBC), carcinoma a cellule squamose della testa e del collo (SCCHN) o carcinoma cervicale, recidivante o refrattario, avanzato e/o metastatico, i quali non sono più candidati alla terapia standard o hanno rifiutato la terapia.
    E.4Principal exclusion criteria
    •Subject has uncontrolled intercurrent illness, including but not limited to:
    • Ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered less than 2 weeks prior to first dose
    • Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia.
    • Uncontrolled hypertension defined as systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg, despite optimal medical management.
    • Ongoing or recent (within 1 year) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
    • Subjects with a history of grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment should be excluded. Subjects with irAEs below grade 3 that led to discontinuation should be discussed with the sponsor.
    • Subjects with a prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade are excluded.
    • History of chronic liver disease or evidence of hepatic cirrhosis.
    • History of non-infectious pneumonitis that has required steroids or currently has pneumonitis.
    • History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1046.
    • Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
    • Any history of intracerebral arteriovenous malformation, cerebral aneurysm or progressive brain metastases or stroke.
    • Prior therapy:
    • Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed.
    • Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab.
    • Subjects who discontinued treatment due to disease progression within the first 6 weeks of a CPI containing treatment.
    • Prior treatment with a 4-1BB (CD137) targeted agent.
    • Prior treatment with a T-cell agonist or anti-CTLA-4 targeted agent within 12 weeks prior to the initiation of treatment.
    • Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to grade 1 or less with the exception of alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to = grade 2.
    Il soggetto è affetto da una malattia intercorrente non controllata, tra cui a titolo esemplificativo e non esaustivo:
    • Infezione in corso o attiva che richieda un trattamento endovenoso con terapia anti-infettiva somministrata meno di 2 settimane prima della prima dose.
    • Insufficienza cardiaca congestizia sintomatica (di grado III o IV secondo la classificazione della New York Heart Association), angina pectoris instabile o aritmia cardiaca.
    • Ipertensione non controllata definita come pressione arteriosa sistolica = 160 mmHg e/o pressione arteriosa diastolica = 100 mmHg, nonostante una gestione medica ottimale.
    • Evidenza in corso o recente (entro 1 anno) di una significativa malattia autoimmune che ha richiesto il trattamento con farmaci immunosoppressivi sistemici, che possono suggerire il rischio di eventi avversi immuno-correlati (irAE).
    • Devono essere esclusi i soggetti con una storia di irAE di grado 3 o superiore che hanno portato all’interruzione di una precedente immunoterapia. I soggetti con irAE al di sotto del grado 3 che hanno portato all’interruzione devono essere sottoposti all’attenzione dello sponsor.
    • Sono esclusi i soggetti con anamnesi pregressa di miosite, sindrome di Guillain-Barré o miastenia grave di qualsiasi grado.
    • Anamnesi di malattia epatica cronica o evidenza di cirrosi epatica.
    • Anamnesi di polmonite non infettiva che abbia richiesto l’utilizzo di steroidi oppure polmonite in atto.
    • Precedente trapianto di organo (ad eccezione del trapianto di cornea) o di trapianto di midollo osseo autologo o allogenico o trapianto di cellule staminali nei 3 mesi precedenti la prima dose di GEN1046.
    • Ferita grave, non cicatrizzante, ulcera cutanea (di qualsiasi grado) o frattura ossea.
    • Trascorsi di malformazione artero-venosa intracerebrale, aneurisma cerebrale, metastasi cerebrali progressive o ictus.
    • Terapia precedente:
    • Radioterapia: radioterapia entro 14 giorni prima della prima somministrazione di GEN1046. La radioterapia palliativa sarà consentita.
    • Salvo diversamente indicato di seguito, trattamento con un agente antitumorale (entro 28 giorni o dopo almeno 5 emivite del farmaco, a seconda di quale sia la più breve), prima della somministrazione di GEN1046. Eccezioni accettate sono i bifosfonati (ad es. pamidronato, acido zoledronico, ecc.) e denosumab.
    • Soggetti che hanno interrotto il trattamento a causa della progressione della malattia nelle prime 6 settimane di un trattamento contenente CPI.
    • Precedente trattamento con un agente diretto contro 4-1BB (CD137).
    • Precedente trattamento con un agonista delle cellule T o un agente mirato anti-CTLA-4 nelle 12 settimane precedenti l’inizio del trattamento.
    • Tossicità da precedenti terapie anti-tumorali che non si sono risolte ai livelli basali o al grado 1 o inferiore, ad eccezione di alopecia, anoressia, vitiligine, stanchezza, ipertiroidismo, ipotiroidismo e neuropatia periferica. Anoressia, ipertiroidismo, ipotiroidismo e neuropatia periferica devono essere guariti a = grado 2.
    E.5 End points
    E.5.1Primary end point(s)
    For Dose Escalation (study part I, that is NOT conducted in Italy):
    - Dose limiting Toxicities (DLTs)
    - Adverse events (AEs) and safety laboratory parameters

    For Dose Expansion (study part 2, that is conducted in Italy):
    - Adverse events (AEs) and safety laboratory parameters
    Per la parte di "aumento progressivo della dose" (parte I dello studio, che NON sarà svolta in Italia):
    • Tossicità dose-limitante (DLT)
    • Eventi avversi (AE) e parametri di laboratorio per la sicurezza

    Per la parte di "espansione della dose" (parte 2 dello studio, che sarà svolta in Italia):
    • Eventi avversi (AE) e parametri di laboratorio per la sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    For Dose Escalation (study part I, that is NOT conducted in Italy):
    - DLTs: dose limiting toxicities will be collected for the first two cycles i.e. DLT period of 42 days.
    - AEs: screening; Day 1, 2, 3, 8, 15 during Cycles 1-2; Days 1, 8, 15 during Cycle 3-4, Day 1 subsequent Cycles (5-PD); EoT; 4, 8, 12, subsequent every 12 (survival follow-up) Weeks after last dosing.

    For Dose Expansion (study part 2, that is conducted in Italy):
    - AEs: screening; Day 1, 2, 3, 8, 15 during Cycles 1-2; Days 1, 8, 15 during Cycle 3-4, Day 1 subsequent Cycles (5-PD); EoT; 4, 8, 12, subsequent every 12 (survival follow-up) Weeks after last dosing.
    Per la parte di "aumento progressivo della dose" (parte I dello studio, che NON sarà svolta in Italia):
    - DLTs: dose limiting toxicities will be collected for the first two cycles i.e. DLT period of 42 days.
    - AEs: screening; Day 1, 2, 3, 8, 15 during Cycles 1-2; Days 1, 8, 15 during Cycle 3-4, Day 1 subsequent Cycles (5-PD); EoT; 4, 8, 12, subsequent every 12 (survival follow-up) Weeks after last dosing.

    Per la parte di "espansione della dose" (parte 2 dello studio, che sarà svolta in Italia):
    - AEs: screening; Day 1, 2, 3, 8, 15 during Cycles 1-2; Days 1, 8, 15 during Cycle 3-4, Day 1 subsequent Cycles (5-PD); EoT; 4, 8, 12, subsequent every 12 (survival follow-up) Weeks after last dosing.
    E.5.2Secondary end point(s)
    For both Dose Escalation (study part I, that is NOT conducted in Italy), and for Dose Expansion (study part 2, that is conducted in Italy):
    - PK parameters
    - Anti-Drug Antibody (ADA) response
    - Anti-tumor activity, i.e., reduction in tumor size according to RECIST 1.1:
    - Objective Response Rate (ORR)
    - Disease Control Rate (DCR)
    - Duration of Response (DoR)
    Sia per la parte di "aumento progressivo della dose" (parte I dello studio, che NON sarà svolta in Italia), e per la parte di "espansione della dose" (parte 2 dello studio, che sarà svolta in Italia):
    • Parametri PK
    • Risposta degli anticorpi anti-farmaco (ADA)
    • Attività antitumorale, ossia riduzione delle dimensioni del tumore secondo RECIST 1.1:
    • Tasso di risposta obiettiva (ORR)
    • Tasso di controllo della malattia (DCR)
    • Durata della risposta (DoR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the entire study
    Durante tutto lo studio
    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 No
    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 Yes
    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 No
    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
    studio in aperto
    open study
    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 trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Hungary
    Israel
    Italy
    Poland
    Spain
    United States
    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
    The trial is considered completed when the last subject dies or withdraws from the trial.
    However, maximal trial duration (for the study part 2, phase IIa) is 2 years after the last subject’s first treatment in study part 2.
    Lo studio si considera completato quando l'ultimo soggetto è deceduto o si ritira dallo studio.
    Comunque la durata massima della parte 2 dello studio (fase IIa) studio è di 2 anni dopo l'inizio del trattamento dell'ultimo soggetto nella parte 2.
    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 years3
    E.8.9.2In all countries concerned by the trial months1
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 380
    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)
    Post trial treatment is at the discretion of the patient's doctor according to standard-of-care per country and site. The Sponsor will ensure post-trial treatment for ongoing trial participants with a potential treatment benefit of GEN1046.
    Il trattamento dopo lo studio è a discrezione del medico del paziente, in accordo allo standard di cura per la nazione e per il centro clinico. Lo sponsor assicurerà il proseguimento del trattamento, dopo la conclusione dello studio, per quei pazienti in studio che hanno mostrato con un potenziale beneficio da GEN1046.
    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 Decision2020-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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