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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 : October 21, 2021
BioNTech SE
Information provided by (Responsible Party):

Brief Summary:
The purpose of the trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors

Condition or disease Intervention/treatment Phase
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 Biological: GEN1046 Biological: GEN1046 in combination with docetaxel (in a single expansion cohort) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 512 participants
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
Official Title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Arm
GEN1046 Open label, single arm trial where GEN1046 will be administered (in one expansion cohort in combination with docetaxel)
Biological: GEN1046
GEN1046 will be administered intravenously once every 21 days (in selected expansion cohorts GEN1046 will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles)

Biological: GEN1046 in combination with docetaxel (in a single expansion cohort)
GEN1046 and docetaxel will be administered intravenously once every 21 days.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03917381

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Contact: Genmab Trial Information +4570202728

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Sponsors and Collaborators
BioNTech SE
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Responsible Party: Genmab Identifier: NCT03917381    
Other Study ID Numbers: GCT1046-01
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

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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
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Carcinoma, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases
Head and Neck Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action