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    Summary
    EudraCT Number:2021-001790-23
    Sponsor's Protocol Code Number:GCT1047-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-001790-23
    A.3Full title of the trial
    First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety study of GEN1047 in patients with malignant solid tumors
    A.3.2Name or abbreviated title of the trial where available
    GEN1047 for Solid Tumors – FIH trial
    A.4.1Sponsor's protocol code numberGCT1047-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05180474
    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 Address Carl Jacobsens Vej 30
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    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®-CD3×B7H4
    D.3.2Product code GEN1047
    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 INNGEN1047-DS
    D.3.9.1CAS number 2640279-10-1
    D.3.9.2Current sponsor codeGEN1047
    D.3.9.3Other descriptive nameDuobody(R)-CD3xB7H4
    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 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.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 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 nameZirconium (89Zr) crefmirlimab berdoxam
    D.3.2Product code Zr-89 crefmirlimab berdoxam
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 Yes
    D.3.11.13.1Other medicinal product typeZr-89 crefmirlimab berdoxam is a PET imaging agent, anti-CD8 minibody with high affinity for CD8 glycoprotein, conjugated with deferoxamine and radiolabeled with 89Zr for imaging CD8+ cells in humans
    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, per protocol GCT1047-01
    E.1.1.1Medical condition in easily understood language
    Solid Tumor
    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 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose Escalation Part:
    • Determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) and recommended phase 2 dose (RP2D), or dose(s) to be
    studied in the Expansion part
    • Characterize the safety profile of GEN1047

    Dose Expansion Part:
    • Evaluate antitumor activity based on response assessment criteria (RECIST v1.1)
    • Determine RP2D (unless determined in the Escalation part)
    E.2.2Secondary objectives of the trial
    Dose Escalation Part:
    • Characterize pharmacokinetic (PK) profile
    • Evaluate immunogenicity of GEN1047
    • Evaluate preliminary antitumor activity

    Dose Expansion Part:
    • Evaluate antitumor activity based on response assessment criteria (RECIST v1.1)
    • Evaluate efficacy
    • Further describe the safety profile of GEN1047
    • Further characterize PK profile
    • Further evaluate immunogenicity of GEN1047
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CD8 PET Imaging Substudy:
    In the Expansion Part of the study, up to 20 subjects in France and
    Denmark will participate in the CD8 PET imaging sub-study as a separate
    cohort with imaging of CD8+ cells using a CD8 PET tracer called
    Zirconium Zr-89 crefmirlimab berdoxam (referenced by the short form
    'Zr-89 crefmirlimab berdoxam).
    The objectives and endpoints for the CD8 PET imaging substudy are
    exploratory only and are in addition to the Expansion objectives and endpoints of the main trial GCT1047-01.
    E.3Principal inclusion criteria
    Criteria - Escalation Part:
    • Subject must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or subject is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer [NSCLC-SCC]).
    • Subjects with ovarian cancer must have documented progressive disease (PD) on or after last prior treatment and within 60 days of Screening.
    • Must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) on the day of signing informed consent.
    • Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting.
    • Must have at least 1 measurable lesion per RECIST v1.1. The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT.
    • Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment.
    • Should provide a tumor tissue sample during the Screening period and prior to C1D1.
    • Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.

    Criteria - Expansion Part:
    • Subjects must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.
    • Subject must have advanced (unresectable) or metastatic, histologically confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer, squamous non-small cell lung cancer [NSCLC-SCC]).
    • Must be a female and at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of consent.
    • Must have at least 1 measurable lesion per RECIST v1.1 as assessed by local investigator.
    • Must have an ECOG- PS score of 0 to 1 at Screening and on Cycle 1 Day 1 (C1D1) pretreatment.
    • Should provide a tumor tissue sample during the Screening period and prior to C1D1.
    • Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.
    E.4Principal exclusion criteria
    •Significant cardiovascular impairment within 6 months of the first dose of trial drug.
    • Subject with new or progressive brain metastases or spinal cord compression.
    • Subject has a history of bowel obstruction related to underlying disease.
    • Subject has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies.
    • Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid.
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation Part:
    • Dose-liming toxicities (DLTs)
    • Adverse events (AEs) and safety laboratory parameters

    Dose Expansion Part:
    • Objective response rate (ORR) based on RECIST v1.1 as assessed by the independent review committee (IRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments will be performed at regular intervals during the trial. Please see protocol for detailed schedule of events for Dose Escalation and Dose Expansion Parts. Safety follow-up visits will be conducted 30 days (+14 days; Dose Escalation and Expansion parts) and 60 days (+14 days;
    Expansion part only) after the subject receives the last dose of GEN1047. Thereafter, survival status will be assessed by contacting subjects every 3 months (±7 days), beginning from the day of the last dose of GEN1047 and continuing until the subject dies, withdraws consent for survival
    status follow up, or the trial ends.
    E.5.2Secondary end point(s)
    Dose Escalation Part:
    • PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; and t1/2)
    • Anti-drug antibody (ADA) incidence
    • Antitumor activity based on Response Evaluation Criteria in Solid Turmors (RECIST v1.1) as assessed by the investigator: Objective response rate (ORR), Duration of response (DOR), Time to response (TTR), Disease control rate (DCR)

    Dose Expansion Part:
    • Antitumor activity, based on RECIST v1.1 as assessed by the IRC: DOR, TTR, DCR
    • Progression-free survival (PFS) based on RECIST v1.1 as assessed by the IRC; Overall Survival (OS)
    • AEs and safety laboratory parameters
    • PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; t1/2)
    • ADA response
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments will be performed at regular intervals during the trial. Please see protocol for detailed schedule of events for Dose Escalation and Dose Expansion Parts. Safety follow-up visits will be conducted 30 days (+14 days; Dose Escalation and Expansion parts) and 60 days (+14 days;
    Expansion part only) after the subject receives the last dose of GEN1047. Thereafter, survival status will be assessed by contacting subjects every 3 months (±7 days), beginning from the day of the last dose of GEN1047 and continuing until the subject dies, withdraws consent for survival
    status follow up, or the trial ends.
    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 No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    United Kingdom
    United States
    Belgium
    Denmark
    France
    Italy
    Netherlands
    Poland
    Spain
    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 trial is considered completed when the last subject dies or withdraws from the trial. However, the maximum trial duration is 5 years after the last subject's first treatment in the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days18
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 500
    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 per standard of care per country. The sponsor will make their best effort to provision post-trial access to GEN1047 for those ongoing subjects with a potential treatment benefit, in accordance with local laws and requirements.
    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 Decision2021-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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