Clinical Trials /

GEN1046 Safety Trial in Patients With Malignant Solid Tumors



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:



Phase 1/Phase 2

Trial Eligibility



  • 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


  • 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


GEN1046 in combination with docetaxel (in a single expansion cohort)Arm


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

ArmExperimentalGEN1046 Open label, single arm trial where GEN1046 will be administered (in one expansion cohort in combination with docetaxel)
  • GEN1046
  • GEN1046 in combination with docetaxel (in a single expansion cohort)

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

               -  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

               -  History of chronic liver disease or evidence of hepatic cirrhosis

               -  History of non-infectious pneumonitis that has required steroids or currently has

               -  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)


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

Last Updated

August 12, 2021