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    Summary
    EudraCT Number:2020-002770-27
    Sponsor's Protocol Code Number:DRA-104-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-002770-27
    A.3Full title of the trial
    Phase 1 and phase 2a, first-in-human study of DRP-104, a glutamine antagonist, in adult patients with advanced solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human (FIH) study of DRP-104 as single agent and in combination with atezolizumab in patients with advanced solid tumors.
    A.4.1Sponsor's protocol code numberDRA-104-001
    A.5.4Other Identifiers
    Name:INDNumber:140589
    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 SponsorDracen Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportDracen Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDracen Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Ops and Ext Collaboration
    B.5.3 Address:
    B.5.3.1Street Address780 Third Avenue; 45th Floor
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19173303971
    B.5.6E-mailflafleur@dracenpharma.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 nameDRP-104
    D.3.4Pharmaceutical form Powder for 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 INNDRP-104
    D.3.9.2Current sponsor codeDRP-104
    D.3.9.3Other descriptive nameDRP-104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name TECENTRIQ
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTecentriq
    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 INNATEZOLIZUMAB
    D.3.9.3Other descriptive nametecentricq
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 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
    Cancer, advanced solid tumors
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    Phase 1 dose escalation and expansion (Parts 1, 2 – Cohort 1 advanced solid tumor, 3, and 4)
    • To characterize the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD)/maximum administered dose (MAD) and recommended phase 2 dose (RP2D) and schedule for future study of DRP-104 as monotherapy and in combination with atezolizumab in patients with advanced solid tumors (excluding primary CNS tumors and HCC)

    Phase 2a (Part 2 – Cohort 2 NSCLC and Cohort 3 SCCHN)
    • To characterize the safety and tolerability of DRP-104 as monotherapy
    • To assess the overall response rate (ORR) of DRP-104 as monotherapy by response evaluation criteria in solid tumors (RECIST) 1.1 in patients with:
    o Locally advanced or metastatic NSCLC whose tumors contain a known mutation in KEAP1, NFE2L2 and/or STK11 – Part 2: Cohort 2 NSCLC
    o Recurrent, unresectable or metastatic SCCHN – Part 2: Cohort 3 SCCHN
    E.2.2Secondary objectives of the trial
    Phase 1 (part 1/2):
    • To characterize the pharmacokinetics (PK) of DRP-104 and its metabolites, M1 and DON, as monotherapy
    • To evaluate the preliminary antitumor activity (ORR) of DRP-104 as monotherapy by RECISTv1.1 in patients with advanced solid tumors (excluding primary CNS tumors and HCC)
    • To evaluate disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS) and overall survival (OS)
    Phase 1 (Parts 3 /4):
    • To characterize the PK of atezolizumab and DRP-104 and its metabolites. M1 and DON
    • To evaluate the preliminary antitumor activity (ORR) of DRP-104 in combination with atezolizumab by RECIST 1.1 and iRECIST in patients with advanced solid tumors
    • To evaluate DCR, DOR, TTR, PFS and OS
    Phase 2a:
    • To characterize the PK of DRP-104 and its metabolites, M1 and DON, as monotherapy
    • To evaluate DCR, DOR, TTR, PFS and OS of DRP-104 monotherapy in specific patient groups as defined in secondary objectives in protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed Informed Consent Form
    • Male or female, 18 years of age or older
    • Target Population:
    o Diagnosis of advanced or recurrent, histologically or cytologically confirmed, solid malignancy that is either metastatic or unresectable
    o Patients must have measurable disease per RECIST 1.1 (Eisenhauer et al., 2009; Schwartz et al., 2016) with the exception of castration-resistant prostate cancer (CRPC) who should have progression based on the PCWG 3.0 criteria (Scher et al., 2016). Lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
    o At time of enrollment, patients must have progressed on, be intolerant of, decline, or be ineligible for, all available standard of care therapies with proven benefit
    Part 2 – dose escalation/phase 2a:
    Cohort 2: locally advanced or metastatic NSCLC with the presence of a known mutation in KEAP1, NFE2L2 and/or STK11.
     The mutational status of KEAP1, NFE2L2, STK11 and KRAS genes will be performed by locally validated DNA tests. Testing will be performed by sequencing DNA extracted from tissue samples and/or from DNA extracted from blood samples using methods of targeting circulating tumor DNA (ctDNA).
     Patients with known EGFR mutations, BRAF V600E mutations, ALK rearrangements, ROS1 rearrangements, and NTRK gene fusions are excluded; other known mutations identified by a locally validated DNA tests are allowed
     Patients must have received at least a platinum doublet chemotherapy and an anti-PD-(L)1 antibody unless patients declined or are ineligible for treatment
     Received no more than 3 lines of systemic anticancer therapy in the recurrent or metastatic setting
    Cohort 3: Recurrent, unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) (the oropharynx, oral cavity, hypopharynx or larynx).
     Patient must have received platinum containing chemotherapy and an anti-PD-(L)1 antibody in the recurrent or metastatic setting, unless patients declined or are ineligible for treatment
    Part 3 and 4 – DRP-104 + Atezolizumab dose escalation/expansion
     Must have prior exposure to therapy with any agent specifically targeting checkpoint pathway inhibition (such as anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 antibody)
     At time of enrollment, patients must have progressed on, be intolerant of, decline, or be ineligible for, all available standard of care therapies with proven benefit.
    • Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1 (see Appendix 1: ECOG Performance Status Criteria)
    • Patient must consent to allow the acquisition of existing FFPE tumor tissue, either a block, which is preferred, or 17 unstained slides, for performance of correlative studies. If an archival tumor sample is not available, patient must consent to allow a newly obtained, pre-treatment tumor biopsy, either core or excisional biopsy of a tumor lesion, preferably not irradiated. Newly obtained biopsies are preferred to archival tissue. Patients unable to provide an archival tumor sample and who either do not consent to a pre-treatment tumor biopsy or do not have accessible lesions are not eligible. If a newly obtained biopsy is required (if no archival), this can be exempt if deemed by the investigator that the biopsy is not being medically feasible for the patient or patient unfit for the procedure (each exemption to be cleared by the Medical Monitor) except for patients with NSCLC (Part 2-Cohort 2) who must submit an archival tumor sample or a newly obtained, pre-treatment tumor biopsy if no archival. However, patients whose pre-treatment biopsy yields inadequate tissue quantity or quality will not be ineligible on this basis alone.
    • All SCCHN patients (Part 1 and Part 2-Cohort 1 and Part 2-Cohort 3), all NSCLC patients (Part 1 and Part 2-Cohort 1, and Part 2-Cohort 2) and patients being treated with the combination of DRP-104 and atezolizumab (Part 4) will be required to undergo pre-treatment and post-treatment core or excisional biopsies. These patients will still require an archival tumor sample. Pre-treatment core or excisional biopsies are optional for all remaining advanced cancer patients enrolled on Part 1, Part 2-Cohort 1, and Part 3; however, if a pre-treatment biopsy is obtained, a post-treatment biopsy must also be obtained. Biopsies will be performed if not considered high risk procedures by the investigator. During the study, this post-treatment biopsy can be exempt if deemed by the investigator that the biopsy is not being medically feasible for the patient or patient unfit for the procedure (each exemption to be cleared by the Medical Monitor).
    For further inclusion criteria, please, refer to protocol
    E.4Principal exclusion criteria
    • Target disease exceptions
    o Patients with primary central nervous system tumors and hepatocellular carcinoma
    o Patients with progressive or symptomatic brain metastases. Patients with brain metastases may be included in this trial as long as the brain metastases have received definitive treatment and are radiologically stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging, [Note: repeat imaging should be performed during study screening]). Patients must be clinically stable and have discontinued anti-seizure medications and steroids, except for physiologic steroid dosing (≤10 mg/day of prednisone equivalents), for at least 14 days prior to Cycle 1 Day 1.
    o Leptomeningeal disease
    o Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 8 weeks prior to Cycle 1 Day 1 and must have discontinued steroids, except for physiologic steroid dosing (≤10 mg/day of prednisone equivalents)
    o Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
     Patients with indwelling catheters (e.g., PleurX) are allowed regardless of drainage frequency
    • Prior therapy
    o Patients who have not recovered to grade 1 or baseline from adverse events (CTCAE v 5.0) related to prior therapy excluding alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ grade 3. Note: any lymphopenia due to previous therapy must have recovered to grade 1 or baseline prior to enrollment.
    o Prior glutaminase inhibitor use (excluded in Part 2: Cohorts 2 and 3 only)
    o Prior systemic anticancer treatment (i.e. chemotherapy, biologic therapy [i.e. small molecular inhibitors], monoclonal antibodies, investigational agents]) within 21 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. If a patient is receiving an anti-PD-1 or anti-PD-L1 antibody on a shorter frequency, ie every two weeks, then the patient is eligible if last dose is 14 days prior to Cycle 1 Day 1. Note: Patients must have recovered from all AEs due to previous therapies to CTCAE v 5.0 grade 1 or baseline, excluding lymphopenia, alopecia, peripheral neuropathy and ototoxicity, which are excluded if > grade 3.
    o Prior small port palliative radiotherapy within 14 days prior to Cycle 1 Day 1 or within 42 days prior to Cycle 1 Day 1 from definitive local control radiation (any dose greater than 50 Gy, within 42 days of Cycle 1 Day1). Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
    o Anti-androgen therapies for prostate cancer, such as bicalutamide, within 4 weeks prior to enrollment. Second-line hormone therapies such as enzalutamide, abiraterone, or orteronel within 2 weeks prior to Cycle 1 Day 1. Patients with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Patients with prostate cancer may also remain on low-dose prednisone or prednisolone up to 10 mg/day.
     Patients with hormone positive breast cancer may remain on endocrine therapy
    o Prior therapy with long acting myeloid growth factor or from a short acting myeloid growth factor within 14 days or 7 days prior to Cycle 1 Day 1
    o Any major surgery within 21 days prior to Cycle 1 Day 1 or who have not recovered from side effects of such procedure
    o Patients receiving potent inducers of CYP 3A4/5 (including St. John’s Wort) that cannot be discontinued at least 14 days prior to Cycle 1 Day 1
    • Medical history and concurrent disease
    o Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
    o Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority
    o Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required.
    o Impairment of gastrointestinal (GI) function or GI disease that may limit the ability to assess GI associated adverse events (e.g. ulcerative disease, uncontrolled nausea and diarrhea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
    Please, refer to protocol for further exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 dose escalation and expansion (Parts 1, 2 –Cohort 1 advanced solid tumor only, 3, and 4):
    • Frequency of DLTs at each dose level associated with DRP-104 as monotherapy and in combination with atezolizumab in a 21 day cycle
    • Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.

    Phase 2a (Part 2 – Cohort 2 NSCLC and Cohort 3 SCCHN):
    • Adverse Events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions and dose intensity.
    • ORR defined as the proportion of patients with a best overall confirmed response of complete response (CR) or partial response (PR) as assessed per RECIST 1.1 by investigator assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    as defined in endpoint and according to assessment schedule
    E.5.2Secondary end point(s)
    Phase 1 single agent dose escalation and expansion (Parts 1 and 2 – Cohort 1 advanced solid tumor cohort only):
    • PK parameters such as but not limited to Cmax, Tmax, AUC, T1/2 and Cmin for DRP-104 and its metabolites (M1, DON).
    • ORR defined as the proportion of patients with a best overall confirmed response (BOR) of complete response (CR) or partial response (PR) as assessed per RECIST 1.1 by investigator assessment
    • Disease control rate (DCR) defined as the proportion of patients with a BOR of CR or PR or SD.
    • Duration of response (DOR), defined as time from date of first documented objective response (CR or PR) to the first documented progression or death due to any cause
    • Time to response (TTR), calculated as time from first dose of study drug to first documented objective response (CR or PR)
    • Progression-free survival (PFS) defined as time from first dose of study drug to progression or death due to any cause
    • Overall survival (OS), defined as time from first dose of study drug to death due to any cause

    Phase 1 DRP-104 + atezolizumab escalation and expansion (Parts 3 and 4)
    • PK parameters such as but not limited to Cmax, Tmax, AUC, T1/2 and Cmin for DRP-104 and its metabolites (M1, DON). Trough concentrations of atezolizumab will be assessed.
    • ORR, defined as the proportion of patients with a BOR of complete response(CR) or partial response (PR) as assessed per RECIST 1.1 and iRECIST by investigator assessment
    • DCR, DOR, TTR, PFS ad OS

    Phase 2a (Part 2 – Cohort 2 NSCLC and Cohort 3 SCCHN cohorts)
    • PK parameters such as but not limited to Cmax, Tmax, AUC, T1/2 and Cmin for DRP-104 and its metabolites (M1, DON)
    • DCR, DOR, TTR, PFS and OS
    • If needed to advance to next steps of development, efficacy parameters will be assessed by independent central review of imaging scans
    E.5.2.1Timepoint(s) of evaluation of this end point
    as defined in endpoint and according to assessment schedule
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability and preliminary antitumor activity
    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 Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Monotherapy and in combination with atezolizumab (different dose of test drug DRP-104)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Monotherapy and in combination with atezolizumab (different dose of test drug DRP-104)
    E.8.2.4Number of treatment arms in the trial2
    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 EEA6
    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
    Germany
    Korea, Republic of
    Singapore
    Spain
    Taiwan
    United States
    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 study will be when all patients have completed at least 12 cycles or 9 months of treatment, whichever is earlier, or discontinued study earlier due to unacceptable toxicity, disease progression via RECIST or iRECIST, death, lost to follow-up, withdrawal of consent, treatment is discontinued at the discretion of the investigator or if the study is terminated early.
    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 months2
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days2
    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: 170
    F.1.3Elderly (>=65 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 170
    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)
    For those patients without progression of disease and still receiving clinical benefit as per their study physician, they will be provided continued access to study drug/treatment on a separate protocol until disease progression.
    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 Decision2021-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
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