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Phase I

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

  • Study HIC#:2000025194
  • Last Updated:01/01/0001

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

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    Trial Purpose and 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.

    Eligibility Criteria

    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

    Principal Investigator

    For more information about this study, including how to volunteer, contact: