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| ID | Type | Description | Link |
|---|---|---|---|
| NL82658.056.23 | Registry Identifier | CCMO (The Netherlands) | |
| 1007620 | Registry Identifier | Research Summaries Database (UK) | |
| 2021-001790-23 | EudraCT Number | ||
| 2024-510722-10 | Other Identifier | EU Trial (CTIS) Number | |
| RECF-004736 | Other Identifier | The French National Cancer Institute |
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The Sponsor has made a strategic decision to stop the development of GEN1047.
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The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047:
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.
The trial is an open-label, multi-center safety trial of GEN1047. The trial consists of two parts: a dose escalation part ("escalation" - phase 1) and an expansion part ("expansion" - phase 2a). The goal of the dose escalation part is to find out if GEN1047 is safe in participants with specific solid tumors and to find the best dose(s). In the expansion part of the trial up to two doses of GEN1047 will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEN1047 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells. | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Escalation: Number of Participants with Dose Limiting Toxicities (DLT) | DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0. | From the first Cycle (Cycle length=21 days) in each cohort |
| Escalation: Number of Participants with Treatment Emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is defined as an AE occurring or worsening between the first dose of study drug and 30 days after the last dose received. | From first dose date up to end of the safety follow up period, 30 days after last dose (approximately 4 months) |
| Expansion: Objective Response Rate (ORR) | ORR is defined as percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Escalation and Expansion: Clearance | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) | |
| Escalation and Expansion: Volume of Distribution (Vd) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
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Key Inclusion Criteria:
Criteria - Escalation Part:
Criteria - Expansion Part Stage 1, 1b and Stage 2:
Key Exclusion Criteria:
Note: Other protocol defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Official | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Medicine Hematology Oncology | Los Angeles | California | 90024 | United States | ||
| Yale University - Yale Cancer Center |
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| Escalation and Expansion: Area Under the Concentration-time Curve from Time 0 to Time of Last Dose (AUClast) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
| Escalation and Expansion: AUC From Time Zero to Infinity (AUC0-inf) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
| Escalation and Expansion: Maximum (Peak) Plasma Concentration (Cmax) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
| Escalation and Expansion: Time to Reach Cmax (Tmax) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
| Escalation and Expansion: Plasma Trough (Pre-dose) Concentrations (Ctrough) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
| Escalation and Expansion: Elimination half-life (t 1/2) | Predose and postdose at multiple timepoints of each Cycle (Cycle length=21 days) |
| Escalation and Expansion: Number of Participants with Anti-Drug Antibody (ADA) | Up to 5 years |
| Escalation: ORR | ORR is defined as percentage of participants with BOR of confirmed CR or confirmed PR based on RECIST v1.1. | Up to 5 years |
| Escalation and Expansion: Duration of Response (DOR) | DOR is defined as the time from the first documented response to the first documented progression or death due to any cause. | Up to 5 years |
| Escalation and Expansion: Time to response (TTR) | Time to response (TTR) is defined as the time from the date of Cycle 1 Day 1 (C1D1) to the first documented response of either confirmed CR or confirmed PR. | Up to 5 years |
| Escalation and Expansion: Disease control rate (DCR) | The disease control rate (DCR) is defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or stable disease (SD) according to RECIST v1.1 | Up to 5 years |
| Expansion: Progression Free Survival (PFS) | PFS is defined as the time from the date of C1D1 to the date of the first documented progression or death due to any cause, whichever occurs earlier according to RECIST v1.1. | Up to 5 years |
| Expansion: Overall Survival (OS) | OS is defined as the time from date of C1D1 to date of death due to any cause. | Up to 5 years |
| Expansion: Number of Participants with TEAEs | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is defined as an AE occurring or worsening between the first dose of study drug and 30 days after the last dose received. | From first dose date up to end of the safety follow up period, 60 days after last dose (approximately 5 months) |
| New Haven |
| Connecticut |
| 06520-8028 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Antwerp University Hospital | Edegem | 2650 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| Rigshospitalet (Copenhagen University Hospital) | Copenhagen | 2100 | Denmark |
| CHU de Besancon | Besançon | 25030 | France |
| Institut Bergonié | Bordeaux | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut du Cancer de Montpellier | Montpellier | 34298 | France |
| Institut Curie | Paris | 75248 | France |
| Hôpital Cochin | Paris | France |
| CHU Poitiers - Hôpital la Milétrie | Poitiers | France |
| Institut Claudius Regaud | Toulouse | France |
| Institut Gustave Roussy | Villejuif | 75005 | France |
| IEO Istituto Europeo di Oncologia | Milan | 435 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | 20900 | Italy |
| University Medical Center Groningen | Groningen | 9713GZ | Netherlands |
| Radboudumc | Nijmegen | 6525GA | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015CE | Netherlands |
| Med-Polonia Sp. z o.o | Poznan | Poland |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Ruber Internacional | Madrid | 28034 | Spain |
| Centro Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Universitary Fundacion Jimenez Diaz | Madrid | 2815 | Spain |
| NEXT Oncology Madrid | Madrid | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Spain |
| St Bartholomews Hospital | London | EC1A7BE | United Kingdom |
| University College London Hospital | London | NW1 2BU | United Kingdom |
| The Christie Hospital | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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