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JOURNAL ONKOLOGIE – STUDIE

GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

Rekrutierend

NCT-Nummer:
NCT04083599

Studienbeginn:
September 2019

Letztes Update:
07.05.2024

Wirkstoff:
GEN1042, Pembrolizumab, Cisplatin, Carboplatin, 5-FU, Gemcitabine, nab paclitaxel, Pemetrexed, Paclitaxel

Indikation (Clinical Trials):
Neoplasms, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Genmab

Collaborator:
BioNTech SE

Kontakt

Studienlocations
(3 von 76)

Nationales Centrum fr Tumorerkrankungen NCT
Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen
(Rheinland-Pfalz)
GermanyAbgeschlossen» Google-Maps
Department of Dermatology, University of Mainz
Mainz
(Rheinland-Pfalz)
GermanyAbgeschlossen» Google-Maps
Universitätsmedizin Mannheim Dermatologie
Mannheim
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitaetsklinikum Wuerzburg
Wuerzburg
(Bayern)
GermanyAbgeschlossen» Google-Maps
Alaska Oncology and Hematology LLC
99508 Anchorage
United StatesRekrutierend» Google-Maps
Cancer & Blood Specialty Clinic
90720 Los Alamitos
United StatesRekrutierend» Google-Maps
Moores Cancer Center at the UC San Diego Health
92037 San Diego
United StatesRekrutierend» Google-Maps
Yale University Cancer Center
06520 New Haven
United StatesRekrutierend» Google-Maps
Mount Sinai Comprehensive Cancer Center
33140 Miami Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Affiliates
34474 Ocala
United StatesRekrutierend» Google-Maps
Hope and Healing Cancer Services
60521 Hinsdale
United StatesRekrutierend» Google-Maps
University of Kentucky
40536 Lexington
United StatesRekrutierend» Google-Maps
Norton Cancer Institute
40202 Louisville
United StatesRekrutierend» Google-Maps
Maryland Oncology Hematology PA
21044 Columbia
United StatesRekrutierend» Google-Maps
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Levine Cancer Center
28204 Charlotte
United StatesRekrutierend» Google-Maps
Novant Health Cancer Institute - Forsyth (Medical Oncology)
27103 Winston-Salem
United StatesRekrutierend» Google-Maps
Kaiser Permanente (KP) Oncology/Hematology
97227 Portland
United StatesRekrutierend» Google-Maps
University of Pennsylvania
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Utah Cancer Specialists
84124 Salt Lake City
United StatesRekrutierend» Google-Maps
Virgina Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-Maps
Adventist Health System/Sunbelt,Inc
98109 Seattle
United StatesRekrutierend» Google-Maps
Medical Oncology Associates, PS
99204 Spokane
United StatesRekrutierend» Google-Maps
Rigshospitalet (Copenhagen University Hospital)
Copenhagen
DenmarkAbgeschlossen» Google-Maps
University Hospital of Southern Denmark, Vejle Hospital
Vejle
DenmarkRekrutierend» Google-Maps
Centre hospitalier Universitaire de Bordeaux
Bordeaux
FranceRekrutierend» Google-Maps
ARENSIA Research Clinic at the Research Institute of Clinical Medicine
Tbilisi
GeorgiaRekrutierend» Google-Maps
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera S.Croce e Carle Cuneo
Cuneo
ItalyRekrutierend» Google-Maps
Chungbuk National University Hospital
Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Jeonbuk National University Hospital
Jeonju
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
Namdong
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Yangsan Hospital
Yangsan
Korea, Republic ofRekrutierend» Google-Maps
ARENSIA Research Clinic at the Oncology Institute
Chisinau
Moldova, Republic ofRekrutierend» Google-Maps
Hospital Duran i Reynals - ICO L Hospitalet
L'Hospitalet De Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitario Insular de Gran Canaria
35016 Las Palmas De Gran Canaria
SpainRekrutierend» Google-Maps
HM CIOCC Hospital Universitario HM Sanchinarro
Madrid
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maran
Madrid
SpainRekrutierend» Google-Maps
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de la Victoria
Málaga
SpainRekrutierend» Google-Maps
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago De Compostela
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
Valencia
SpainRekrutierend» Google-Maps
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Kaohsiung City
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Memorial Hospital
Kaohsiung City
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital, VGHTPE
Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Hospital Linkou Branch
Taoyuan
TaiwanRekrutierend» Google-Maps
Royal Marsden NHS Foundation Trust
Sutton
United KingdomAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is an open-label, multicenter phase 1/2 study designed to assess the safety,

pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a

monotherapy or in combination in subjects with metastatic or locally advanced solid tumors.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

- Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom

there is no available standard therapy.

- Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or

metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy

Combination Therapy - Dose Expansion Part

- Subjects with unresectable Stage III or Stage IV melanoma with no prior systemic

anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal

melanoma is excluded.

- Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer

therapy, no actionable mutation.

- Subjects with recurrent or metastatic HNSCC with no prior systemic therapy

administered in the recurrent or metastatic setting.

- Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery,

chemotherapy, or investigational therapy for the treatment of metastatic disease.

General (all phases):

- Must be age ≥ 18 years of age on the day of signing informed consent, or the legal age

of consent in the jurisdiction in which the trial is taking place.

- Measurable disease according to RECIST 1.1

- Eastern Cooperative Oncology Group (ECOG) 0-1

- Normal or adequate liver, renal, cardiac and bone marrow function

Key Exclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

- Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of

the drug, whichever is shorter), prior to GEN1042 administration

- Radiotherapy within 14 days prior to first GEN1042 administration

- Toxicities from previous anti-cancer therapies that have not resolved

Combination Therapy - Dose Expansion Part

- Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major

surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of

the first dose of trial treatment.

- Radiotherapy within 14 days of start of trial treatment or received lung radiation

therapy of > 30 Gy within 6 months of the first dose of trial treatment.

General (all phases)

- Subject has an active, known, or suspected autoimmune disease.

- History of non-infectious pneumonitis that required steroids or currently has

pneumonitis.

- History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy

- Subject with a condition requiring systemic treatment with either corticosteroids (>10

mg daily prednisone equivalent) or other immunosuppressive medications within 14 days

of first treatment.

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

Studien-Rationale

Primary outcome:

1. Percentage of Subjects With Dose-Limiting Toxicities (DLT) (Time Frame - First Cycle (21 days)):
Occurrence of Dose-Limiting Toxicities (DLT) assessed by the Investigator

2. Objective Response Rate (ORR) (Time Frame - From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)):
Defined as proportion of participants who have a confirmed partial or complete response (PR or CR). Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary outcome:

1. Percentage of Subjects with Adverse Events and Serious Adverse Events (Time Frame - Baseline up to 90 Days After the Last Dose, assessed up to 36 months after the last subject's first treatment in the trial.):
Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0

2. Duration of Object Response (DOR) (Time Frame - From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)):
Defined as time from the first documentation of objective response (CR or PR) to the date of first PD or death.

3. Disease Control Rate (DCR) (Time Frame - From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)):
Determined by Investigator Using RECIST Version 1.1

4. Progression-Free Survival (PFS) (Time Frame - From the start of the study treatment until disease progression/death whichever occurs first. (an expected average of 10 months)):
Defined as the time from start of study treatment to first documented progression per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.

5. Overall survival (OS) (Time Frame - From the start of the study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.):
Defined as the time from start of study treatment to date of death due to any cause.

6. Dose Escalation: Maximum Concentration (Cmax) of GEN1042 (Time Frame - Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and End of Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)):
Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Maximum Concentration (Cmax) of GEN1042

7. Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042 (Time Frame - Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and , End of GEN1042 Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)):
Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042

8. Dose Escalation: Half-life (t1/2) of GEN1042 (Time Frame - Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and End of Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)):
Dose Escalation: Half-life (t1/2) of GEN1042

9. Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042 (Time Frame - Cy 1 BI, EOI on D1, D8, 15, Cy 2 BI, EOI on D1, D8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)):
Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042

10. Dose Expansion: Maximum Concentration (Cmax) of GEN1042 (Time Frame - Cy 1 BI, EOI on D1, D8, 15, Cy 2 BI, EOI on D1, D8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)):
Dose Expansion: Maximum Concentration (Cmax) of GEN1042

11. Dose Escalation: Incidence of ADA response to GEN1042 (Time Frame - BI on Cy 1, 2, 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment), safety follow-up visit (SFU) (30 and 90 days post final dose) (Cy =21 days)):
Dose Escalation: Incidence of ADA response to GEN1042responses to GEN1042

12. Dose Expansion: Incidence of ADA response to GEN1042 (Time Frame - BI on Cy 1, 2, 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment), SFU (30 and 90 days post final dose) (Cy =21 days)):
Dose Expansion: Incidence of ADA response to GEN1042

Studien-Arme

  • Experimental: Monotherapy - Dose Escalation and Dose Expansion parts
    Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).
  • Experimental: Combination Therapy - Dose Expansion Part
    GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer.

Geprüfte Regime

  • GEN1042:
    Intravenous
  • Pembrolizumab:
    Intravenous
  • Cisplatin:
    Intravenous
  • Carboplatin:
    Intravenous
  • 5-FU:
    Intravenous
  • Gemcitabine:
    Intravenous
  • Nab paclitaxel:
    Intravenous
  • Pemetrexed:
    Intravenous
  • Paclitaxel:
    Intravenous

Quelle: ClinicalTrials.gov


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