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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03625037




Registration number
NCT03625037
Ethics application status
Date submitted
7/06/2018
Date registered
10/08/2018
Date last updated
5/11/2024

Titles & IDs
Public title
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Scientific title
A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Secondary ID [1] 0 0
2017-001748-36
Secondary ID [2] 0 0
GCT3013-01
Universal Trial Number (UTN)
Trial acronym
EPCORE™ NHL-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
DLBCL 0 0
High-grade B-cell Lymphoma (HGBCL) 0 0
Primary Mediastinal Large B-cell Lymphoma (PMBCL) 0 0
FL 0 0
MCL 0 0
Small Lymphocytic Lymphoma (SLL) 0 0
Marginal Zone Lymphoma (MZL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Epcoritamab

Experimental: Epcoritamab - Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.


Treatment: Other: Epcoritamab
Administered as specified in the treatment arm.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-Escalation: Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
During the first cycle (28 days) in each Dose-OPT Part DLBCL, FL and MCL
Primary outcome [2] 0 0
Dose-Escalation: Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
From first dose until the end of the safety follow-up period (Up to 1 year)
Primary outcome [3] 0 0
Expansion and Dose-OPT MCL: Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to 1.5 years
Primary outcome [4] 0 0
Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
Timepoint [4] 0 0
From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)
Secondary outcome [1] 0 0
Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [2] 0 0
Dose-Escalation: DOR
Timepoint [2] 0 0
Up to 1 year
Secondary outcome [3] 0 0
Expansion: DOR
Timepoint [3] 0 0
Up to 1.5 years
Secondary outcome [4] 0 0
Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Timepoint [4] 0 0
Up to 1.5 year
Secondary outcome [5] 0 0
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
Timepoint [5] 0 0
Up to 1.5 years
Secondary outcome [6] 0 0
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
Timepoint [6] 0 0
Up to 1.5 years
Secondary outcome [7] 0 0
Dose-OPT DLBCL and FL: ORR
Timepoint [7] 0 0
Up to 1.5 years
Secondary outcome [8] 0 0
Dose-OPT DLBCL and FL: CR Rate
Timepoint [8] 0 0
Up to 1.5 years
Secondary outcome [9] 0 0
Dose-OPT DLBCL and FL: Duration of CR (DoCR)
Timepoint [9] 0 0
Up to 1.5 years
Secondary outcome [10] 0 0
Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
Timepoint [10] 0 0
Up to 1.5 years
Secondary outcome [11] 0 0
Dose-OPT DLBCL and FL: DLT
Timepoint [11] 0 0
During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
Secondary outcome [12] 0 0
Dose-OPT MCL: Time to Complete Response (TTCR)
Timepoint [12] 0 0
Up to 1.5 years
Secondary outcome [13] 0 0
Dose-OPT DLBCL, FL and MCL: DOR
Timepoint [13] 0 0
Up to 1.5 years
Secondary outcome [14] 0 0
Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab
Timepoint [14] 0 0
Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days)
Secondary outcome [15] 0 0
Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
Timepoint [15] 0 0
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
Secondary outcome [16] 0 0
Expansion and Dose-OPT MCL: CR Rate
Timepoint [16] 0 0
Up to 1.5 years
Secondary outcome [17] 0 0
Expansion and Dose-OPT MCL: DoCR
Timepoint [17] 0 0
Up to 1.5 years
Secondary outcome [18] 0 0
Expansion and Dose-OPT MCL: ORR
Timepoint [18] 0 0
Up to 1.5 years
Secondary outcome [19] 0 0
Expansion and Dose-OPT MCL: Time to Response (TTR)
Timepoint [19] 0 0
Up to 1.5 years
Secondary outcome [20] 0 0
Expansion and Dose-OPT MCL: CR Rate
Timepoint [20] 0 0
Up to 1.5 years
Secondary outcome [21] 0 0
Expansion and Dose-OPT MCL: PFS
Timepoint [21] 0 0
Up to 1.5 years
Secondary outcome [22] 0 0
Expansion and Dose-OPT MCL: DOR
Timepoint [22] 0 0
Up to 1.5 years
Secondary outcome [23] 0 0
Expansion and Dose-OPT MCL: DoCR
Timepoint [23] 0 0
Up to 1.5 years
Secondary outcome [24] 0 0
Expansion and Dose-OPT MCL: TTR
Timepoint [24] 0 0
Up to 1.5 years
Secondary outcome [25] 0 0
Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
Timepoint [25] 0 0
Up to 7 years and 6 months
Secondary outcome [26] 0 0
Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
Timepoint [26] 0 0
Up to 1.5 years
Secondary outcome [27] 0 0
All Parts: Number of Participants with CRS Events
Timepoint [27] 0 0
Up to Day 1 of Cycle 12 (Cycle length=28 days)
Secondary outcome [28] 0 0
All Parts: Immunophenotyping for Absolute T-cell and B-cell
Timepoint [28] 0 0
Up to Day 1 of Cycle 12 (Cycle length=28 days)
Secondary outcome [29] 0 0
All Parts: T-Cell Activation and Exhaustion Marker
Timepoint [29] 0 0
Up to 7 years and 6 months
Secondary outcome [30] 0 0
All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL)
Timepoint [30] 0 0
Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
Secondary outcome [31] 0 0
All Parts: Area under Curve (AUC) of Epcoritamab
Timepoint [31] 0 0
Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
Secondary outcome [32] 0 0
All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab
Timepoint [32] 0 0
Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
Secondary outcome [33] 0 0
All Parts: Time to Reach Cmax of Epcoritamab
Timepoint [33] 0 0
Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
Secondary outcome [34] 0 0
All Parts: Half Life of Epcoritamab (t1/2)
Timepoint [34] 0 0
Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
Secondary outcome [35] 0 0
All Parts: Number of Participants with Anti-drug Antibody (ADA)
Timepoint [35] 0 0
Up to 7 years and 6 months
Secondary outcome [36] 0 0
All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
Timepoint [36] 0 0
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
Secondary outcome [37] 0 0
All Parts: Overall survival (OS)
Timepoint [37] 0 0
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

Eligibility
Key inclusion criteria
Main Inclusion Criteria - Escalation Part (recruitment completed)

* Documented CD20+ mature B-cell neoplasm

1. DLBCL - de novo or transformed
2. HGBCL
3. PMBCL
4. FL
5. MCL
6. SLL
7. MZL (nodal, extranodal or mucosa associated)
* Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
* Participants must have measurable disease by CT, MRI or Positron emission tomography-Computed tomography (PET-CT) scan
* Acceptable renal function.
* Acceptable liver function.

Main Inclusion Criteria - Expansion & Dose-OPT Parts

* Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
* DLBCL, de novo or transformed (including double hit or triple hit).
* PMBCL
* FL grade 3B
* Histologic confirmed FL
* MZL
* SLL
* MCL (prior BTKi or intolerant to BTKi)
* At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen.
* Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or ineligible for autologous stem cell transplantation due to age or comorbidities.
* At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria - All Parts

* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
* Known past or current malignancy other than inclusion diagnosis.
* AST, and/or ALT >3 × upper limit of normal.
* Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
* Estimated Creatinine clearance (CrCl) <45 mL/min.
* Known clinically significant cardiovascular disease.
* Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor.
* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
* Seizure disorder requiring therapy (such as steroids or anti-epileptics).
* Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20.
* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration.
* Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue.
* Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation.
* Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Participants with evidence of prior HBV but who are PCR-negative are permitted in
* Known human immunodeficiency virus (HIV) infection.
* Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF).
* Pregnancy or breast feeding.
* Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant.
* Contraindication to all uric acid lowering agents.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
Accrual to date
Final
666
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
St. Vincent Hospital - Fitzroy
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Royal Hobart Hospital RHH - Hobart
Recruitment hospital [6] 0 0
St. George Hospital - Kogarah
Recruitment hospital [7] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [9] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [10] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Nedlands
Recruitment postcode(s) [9] 0 0
- Southport
Recruitment postcode(s) [10] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Canada
State/province [16] 0 0
Calgary
Country [17] 0 0
Canada
State/province [17] 0 0
Toronto
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen
Country [19] 0 0
Denmark
State/province [19] 0 0
Odense
Country [20] 0 0
Denmark
State/province [20] 0 0
Vejle
Country [21] 0 0
Finland
State/province [21] 0 0
Helsinki
Country [22] 0 0
Finland
State/province [22] 0 0
Kuopio
Country [23] 0 0
Finland
State/province [23] 0 0
Tampere
Country [24] 0 0
France
State/province [24] 0 0
Créteil
Country [25] 0 0
France
State/province [25] 0 0
Montpellier
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Pierre-Bénite
Country [28] 0 0
France
State/province [28] 0 0
Rouen cedex
Country [29] 0 0
France
State/province [29] 0 0
Tours
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Cologne
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Mainz
Country [34] 0 0
Germany
State/province [34] 0 0
München
Country [35] 0 0
Italy
State/province [35] 0 0
Alessandria
Country [36] 0 0
Italy
State/province [36] 0 0
Bologna
Country [37] 0 0
Italy
State/province [37] 0 0
Candiolo
Country [38] 0 0
Italy
State/province [38] 0 0
Meldola
Country [39] 0 0
Italy
State/province [39] 0 0
Milan
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Busan
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Daegu
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Goyang-si
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Jeonju
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seongnam-si
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Maastricht
Country [48] 0 0
Netherlands
State/province [48] 0 0
Rotterdam
Country [49] 0 0
Netherlands
State/province [49] 0 0
Utrecht
Country [50] 0 0
Poland
State/province [50] 0 0
Bydgoszcz
Country [51] 0 0
Poland
State/province [51] 0 0
Gdansk
Country [52] 0 0
Poland
State/province [52] 0 0
Kraków
Country [53] 0 0
Poland
State/province [53] 0 0
Slupsk
Country [54] 0 0
Poland
State/province [54] 0 0
Warszawa
Country [55] 0 0
Poland
State/province [55] 0 0
Wroclaw
Country [56] 0 0
Singapore
State/province [56] 0 0
Singapore
Country [57] 0 0
Spain
State/province [57] 0 0
Navarra
Country [58] 0 0
Spain
State/province [58] 0 0
Badalona
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Sweden
State/province [61] 0 0
Lund
Country [62] 0 0
Sweden
State/province [62] 0 0
Stockholm
Country [63] 0 0
Sweden
State/province [63] 0 0
Uppsala
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Manchester
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Plymouth
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Southampton
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):

* The dose schedule for epcoritamab
* The side effects seen with epcoritamab
* What the body does with epcoritamab once it is administered
* What epcoritamab does to the body once it is administered
* How well epcoritamab works against relapsed and/or refractory B-cell lymphoma

The trial consists of 3 parts:

* a dose-escalation part \[Phase 1, first-in-human (FIH)\]
* an expansion part (Phase 2a)
* a dose-optimization part (OPT) (Phase 2a)

The trial time for each participant depends on which trial part the participant enters:

* For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
* For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).

Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.

All participants will receive active drug, and no participants will be given placebo.
Trial website
https://clinicaltrials.gov/study/NCT03625037
Trial related presentations / publications
Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.
Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, Christensen JH, Hess B, Tilly H, Cordoba R, Lewis DJ, Okada C, Hutchings M, Clausen MR, Sancho JM, Cochrane T, Leppa S, Chamuleau MED, Gernhardt D, Altintas I, Liu Y, Ahmadi T, Dinh MH, Hoehn D, Favaro E, Elliott B, Thieblemont C, Vose JM. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024 Aug;11(8):e593-e605. doi: 10.1016/S2352-3026(24)00166-2. Epub 2024 Jun 15.
Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
Public notes

Contacts
Principal investigator
Name 0 0
Study Official
Address 0 0
Genmab
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03625037