History of Changes for Study: NCT03917381
GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Latest version (submitted January 14, 2022) on
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Study Record Versions
Version A B Submitted Date Changes
1 April 12, 2019 None (earliest Version on record)
2 May 20, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 June 7, 2019 Study Status and Contacts/Locations
4 July 10, 2019 Study Status and Contacts/Locations
5 November 12, 2019 Study Status and Contacts/Locations
6 January 30, 2020 Study Status and Contacts/Locations
7 March 24, 2020 Study Status and Contacts/Locations
8 May 26, 2020 Study Status and Contacts/Locations
9 June 18, 2020 Contacts/Locations and Study Status
10 August 13, 2020 Study Status and Contacts/Locations
11 August 31, 2020 Contacts/Locations, Study Design and Study Status
12 March 2, 2021 Contacts/Locations and Study Status
13 March 30, 2021 Arms and Interventions, Study Status and Study Design
14 June 1, 2021 Study Status and Contacts/Locations
15 August 11, 2021 Study Status and Contacts/Locations
16 October 13, 2021 Study Status and Arms and Interventions
17 January 14, 2022 Study Status, Outcome Measures, Arms and Interventions, Eligibility, Study Design, Study Description and Study Identification
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Study NCT03917381
Submitted Date:  April 12, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: GCT1046-01
Brief Title: GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Official Title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2019
Overall Status: Not yet recruiting
Study Start: May 2019
Primary Completion: October 2021 [Anticipated]
Study Completion: February 2022 [Anticipated]
First Submitted: April 11, 2019
First Submitted that
Met QC Criteria:
April 12, 2019
First Posted: April 17, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
April 12, 2019
Last Update Posted: April 17, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Genmab
Responsible Party: Sponsor
Collaborators: BioNTech SE
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors
Detailed Description: The trial is an open-label, multi-center safety trial of GEN1046. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a)). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
Open or close this module Conditions
Conditions: Solid Tumors
Non-small Cell Lung Cancer
Urothelial Carcinoma
Endometrial Carcinoma
Triple Negative Breast Cancer
Squamous Cell Carcinoma of the Head and Neck
Cervical Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
The starting dose is administered as a flat dose. Dose escalation steps are based on safety data
Number of Arms: 1
Masking: None (Open Label)
Enrollment: 192 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm
GEN1046 Open label, single arm trial where GEN1046 will be administered
Biological: GEN1046
GEN1046 will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Dose limiting toxicity (DLT)
[ Time Frame: DLTs are assessed during the first cycle (21 days) in each cohort] ]

to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
2. Adverse events
[ Time Frame: AEs are collected throughout the study and up to 2 months after last subject last treatment ]

Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
3. Safety laboratory parameters (hematology, biochemistry, coagulation, endocrines)
[ Time Frame: Safety laboratory data are collected throughout the study and up to 2 months after last subject last treatment ]

Laboratory parameters graded by CTCAE v5.0
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

Inclusion Criteria:

For Dose Escalation:

• Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy

For Expansion:

• Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy

For Both Dose Escalation and Expansion

  • Have measurable disease according to RECIST 1.1
  • Have Eastern Cooperative Oncology Group (ECOG) 0-1
  • Have an acceptable hematological status
  • Have acceptable liver function
  • Have an acceptable coagulation status
  • Have acceptable renal function

Exclusion Criteria:

  • Have uncontrolled intercurrent illness, including but not limited to:
    • Ongoing or active infection requiring intravenous treatment with antiinfective therapy
    • Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia
    • Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management
    • Ongoing or recent evidence of autoimmune disease
    • History of irAEs that led to prior checkpoint treatment discontinuation
    • Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade
    • History of chronic liver disease or evidence of hepatic cirrhosis
    • History of non-infectious pneumonitis that has required steroids or currently has pneumonitis
    • History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1046
    • Serious, non-healing wound, skin ulcer (of any grade), or bone fracture
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
  • Prior therapy:
    • Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed.
    • Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab
  • Toxicities from previous anti-cancer therapies that have not adequately resolved
Open or close this module Contacts/Locations
Central Contact Person: Genmab Trial Information
Telephone: +4570202728
Locations: Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Contact:Contact: Ravit Geva
Sheba Medical Center, Ramat Gan
Tel HaShomer, Israel, 52621
Contact:Contact: Eytan Ben-Ami
Hospital Universitario Vall dHebron
Barcelona, Spain, 08035
Contact:Contact: Elena Garralda Cabanas
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Contact:Contact: Ignacio Melero
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services