Clinical Trials /

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

NCT03917381

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Cervical Carcinoma
  • Endometrial Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: GCT1046-01
  • NCT ID: NCT03917381

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

Interventions

DrugSynonymsArms
GEN1046Arm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
ArmExperimentalGEN1046 Open label, single arm trial where GEN1046 will be administered
  • GEN1046

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicity (DLT)
Time Frame:DLTs are assessed during the first cycle (21 days) in each cohort]
Safety Issue:
Description:to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genmab

Last Updated

May 26, 2020