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A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

15. September 2026 aktualisiert von: Merck Sharp & Dohme LLC

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:

  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment
  • Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:

  • About the safety of I-DXd and if children younger than 12 years old tolerate it
  • How many children who receive I-DXd have the cancer get smaller or go away

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study will have 2 parts: Part 1 will evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd, followed by Part 2 an efficacy expansion.

Studientyp

Interventionell

Einschreibung (Geschätzt)

134

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Belgien
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgien, 9000
        • Rekrutierung
        • UZ Gent ( Site 4428)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +32 9 332 16 53
  • Dänemark
    • Capital Region
      • Copenhagen, Capital Region, Dänemark, DK-2100
        • Rekrutierung
        • Rigshospitalet ( Site 4467)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +4535455002
  • Frankreich
    • Aquitaine
      • Bordeaux, Aquitaine, Frankreich, 33076
        • Rekrutierung
        • Bordeaux University Hospital - Pellegrin ( Site 4105)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +33 5 56 79 56 79
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Frankreich, 44093
        • Rekrutierung
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +33240087805
    • Rhone
      • Lyon, Rhone, Frankreich, 69373
        • Rekrutierung
        • CENTRE LEON BERARD ( Site 4100)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +33469166572
  • Israel
      • Haifa, Israel, 3109601
        • Rekrutierung
        • Rambam Health Care Campus ( Site 4674)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +97247776755
      • Ramat Gan, Israel, 5265601
        • Rekrutierung
        • Sheba Medical Center ( Site 4675)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +97235302996
  • Schweden
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Schweden, 416 85
        • Rekrutierung
        • Sahlgrenska Universitetssjukhuset ( Site 4634)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +46313435865
  • Spanien
      • Barcelona, Spanien, 08035
        • Rekrutierung
        • Hospital Universitari Vall d Hebron ( Site 4716)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +34934893093
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spanien, 8950
        • Rekrutierung
        • Hospital Sant Joan de Déu ( Site 4717)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +34671600093
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanien, 28009
        • Rekrutierung
        • Hospital Niño Jesús ( Site 4715)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +34915035900
  • Südkorea
      • Seoul, Südkorea, 03080
        • Rekrutierung
        • Seoul National University Hospital-Pediatrics ( Site 4972)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 82220723304
      • Seoul, Südkorea, 05505
        • Rekrutierung
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 82230105994
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90027
        • Rekrutierung
        • Children's Hospital Los Angeles ( Site 4006)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 323-361-2121
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • Rekrutierung
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 720-777-6740
    • Iowa
      • Iowa City, Iowa, Vereinigte Staaten, 52242
        • Rekrutierung
        • University of Iowa Hospitals ( Site 4017)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 319-356-2296
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02215
        • Rekrutierung
        • Dana Farber Cancer Center ( Site 4013)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 617-632-4580
    • Michigan
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Rekrutierung
        • Corewell Health ( Site 4001)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 616-486-0746
    • New Jersey
      • New Brunswick, New Jersey, Vereinigte Staaten, 08901
        • Rekrutierung
        • Rutgers Cancer Institute of New Jersey ( Site 4008)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 732-235-2465
    • New York
      • New York, New York, Vereinigte Staaten, 10065
        • Rekrutierung
        • Memorial Sloan Kettering Cancer Center ( Site 4010)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 888-492-8401
      • Valhalla, New York, Vereinigte Staaten, 10595
        • Rekrutierung
        • New York Medical College ( Site 4023)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 914-614-4270
    • North Dakota
      • Fargo, North Dakota, Vereinigte Staaten, 58102
        • Rekrutierung
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 701-234-2000
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Rekrutierung
        • Children's Hospital of Philadelphia (CHOP) ( Site 4021)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 267-425-5544
    • South Dakota
      • Sioux Falls, South Dakota, Vereinigte Staaten, 57105
        • Rekrutierung
        • Sanford Children's Hospital ( Site 4015)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 605-312-1000
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • University of Texas M.D. Anderson Cancer Center ( Site 4007)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 713-792-5410
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84113
        • Rekrutierung
        • Intermountain - Primary Children's Hospital ( Site 4014)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 801-662-4700

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

The main inclusion criteria include but are not limited to the following:

  • In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
  • Is an individual of any sex/gender, ≥1 month to <12 years of age for Part 1 and ≥1 month to <18 years for Part 2 at the time of providing the informed consent or assent, as applicable
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

The main exclusion criteria include but are not limited to the following:

  • Has clinically significant corneal disease
  • Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
  • Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
  • Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
  • Has an active, known or suspected autoimmune disease.
  • Has history of solid organ transplant.
  • Has history of allogeneic stem cell transplant (SCT).
  • Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • Has active infection requiring systemic therapy
  • Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Biologisch: Ifinatamab Deruxtecan
IV infusion
Andere Namen:
  • DS-7300a
  • I-DXd
  • MK-2400

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Zeitfenster: Cycle 1 (up to approximately 21 days); each cycle is 21 days
A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.
Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)
Zeitfenster: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE
Zeitfenster: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs
Zeitfenster: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)
Zeitfenster: Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
Zeitfenster: Up to 4 Months
DCS-4 is defined as no occurrence of disease progression per disease specific criteria as assessed by investigator or death due to any cause by Month 4 following the first administration of study intervention for participants with OST. Participants who discontinue from study for any reason prior to completing the third post baseline (or at least 16 weeks) response assessments will be considered disease control failures.
Up to 4 Months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Teil 1 und Teil 2: Gesamtüberleben (OS)
Zeitfenster: Bis zu ungefähr 5 Jahre
OS wird von der ersten Dosis der Studienbehandlung bis zu dem Tod aufgrund jeglicher Ursache definiert.
Bis zu ungefähr 5 Jahre
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
Zeitfenster: Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST
Zeitfenster: Up to approximately 5 years
DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST
Zeitfenster: Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST
Zeitfenster: Up to approximately 5 years
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: ORR For participants with OST
Zeitfenster: Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants with OST who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience an AE
Zeitfenster: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE
Zeitfenster: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose Modification Due to an AE
Zeitfenster: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of I-Dxd
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of I-Dxd
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-Dxd
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of released drug payload (Dxd)
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of Dxd
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Dxd
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Number of Participants with antidrug antibodies (ADA) against I-Dxd
Zeitfenster: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to assess I-Dxd immunogenicity by determining the incidence of ADA of I-Dxd.
At designated timepoints (up to approximately 5 years)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Mitarbeiter

Daiichi Sankyo

Ermittler

  • Studienleiter: Medical Director, Merck Sharp & Dohme LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Juli 2026

Primärer Abschluss (Geschätzt)

17. August 2031

Studienabschluss (Geschätzt)

17. August 2031

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 9999-01D
  • 2025 (US NIH Stipendium/Vertrag: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (Andere Kennung: MSD)
  • U1111-1322-6561 (Registrierungskennung: UTN)
  • 2025-522339-32-00 (Registrierungskennung: EU CT)
  • MK-9999-01D (Andere Kennung: MSD)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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