Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
179 participants
INTERVENTIONAL
2021-12-13
2026-03-26
Brief Summary
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* The side effects seen with GEN1047
* What the body does with GEN1047 once it is administered
* What GEN1047 does to the body once it is administered
* How well GEN1047 works against solid tumors
The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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GEN1047
GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.
GEN1047 will be administered as an intravenous infusion. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.
Interventions
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GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.
GEN1047 will be administered as an intravenous infusion. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant 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 participant 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, NSCLC-SCC.
* Participants 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 Stage 1, 1b and Stage 2:
* Participants 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.
* Participant must have advanced (unresectable) or metastatic, histologically confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer.
* 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.
* Must submit 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.
Exclusion Criteria
* Participant with new or progressive brain metastases or spinal cord compression.
* Participant 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.
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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UCLA Department of Medicine Hematology Oncology
Los Angeles, California, United States
Yale University - Yale Cancer Center
New Haven, Connecticut, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Antwerp University Hospital
Edegem, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Rigshospitalet (Copenhagen University Hospital)
Copenhagen, , Denmark
CHU de Besancon
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
Institut du Cancer de Montpellier
Montpellier, , France
Institut Curie
Paris, , France
Hôpital Cochin
Paris, , France
CHU Poitiers - Hôpital la Milétrie
Poitiers, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
IEO Istituto Europeo di Oncologia
Milan, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, , Italy
University Medical Center Groningen
Groningen, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Med-Polonia Sp. z o.o
Poznan, , Poland
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Centro Oncologico Clara Campal
Madrid, , Spain
Hospital Universitary Fundacion Jimenez Diaz
Madrid, , Spain
NEXT Oncology Madrid
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
St Bartholomews Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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NL82658.056.23
Identifier Type: REGISTRY
Identifier Source: secondary_id
1007620
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-001790-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-510722-10
Identifier Type: OTHER
Identifier Source: secondary_id
RECF-004736
Identifier Type: OTHER
Identifier Source: secondary_id
GCT1047-01
Identifier Type: -
Identifier Source: org_study_id
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