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GEN1046 Safety Trial in Patients With Malignant Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03917381
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : June 2, 2021
BioNTech SE
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE May 14, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Official Title  ICMJE First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
The starting dose is administered as a flat dose. Dose escalation steps are based on safety data
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Biological: GEN1046
    GEN1046 will be administered intravenously once every 21 days.
  • Biological: GEN1046 in combination with docetaxel (in a single expansion cohort)
    GEN1046 and docetaxel will be administered intravenously once every 21 days.
Study Arms  ICMJE Experimental: Arm
GEN1046 Open label, single arm trial where GEN1046 will be administered (in one expansion cohort in combination with docetaxel)
  • Biological: GEN1046
  • Biological: GEN1046 in combination with docetaxel (in a single expansion cohort)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Genmab Trial Information +4570202728
Listed Location Countries  ICMJE Czechia,   Hungary,   Israel,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03917381
Other Study ID Numbers  ICMJE GCT1046-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genmab
Study Sponsor  ICMJE Genmab
Collaborators  ICMJE BioNTech SE
Investigators  ICMJE Not Provided
PRS Account Genmab
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP