Clinical Trials /

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

NCT04937153

Description:

This is an open-label, single-country, multicenter, phase 1 dose escalation trial to assess the safety and pharmacokinetics (PK) of GEN1046.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies
  • Official Title: Open-label, Dose-escalation Trial to Evaluate the Safety and Pharmacokinetics of GEN1046 in Japanese Subjects With Advanced Solid Malignancies

Clinical Trial IDs

  • ORG STUDY ID: GCT1046-02
  • NCT ID: NCT04937153

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
GEN1046GEN1046 (DuoBody®-PD-L1x4-1BB)Single arm

Purpose

This is an open-label, single-country, multicenter, phase 1 dose escalation trial to assess the safety and pharmacokinetics (PK) of GEN1046.

Detailed Description

      The purpose of the trial is to evaluate the safety and pharmacokinetics of GEN1046 in
      Japanese subjects with malignant solid tumors.
    

Trial Arms

NameTypeDescriptionInterventions
Single armExperimentalGEN1046 open label, single arm trial where GEN1046 will be administered
  • GEN1046

Eligibility Criteria

        Key Inclusion Criteria:

          -  Asian race and Japanese ethnicity

          -  Have a histologically or cytologically confirmed non-CNS solid tumor that is
             metastatic or unresectable and for whom there is no available standard therapy

          -  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

        Key Exclusion Criteria:

          -  Have uncontrolled intercurrent illness, including but not limited to:

               -  Ongoing or active infection requiring intravenous treatment with anti-infective
                  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:20 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:The occurrence of any toxicities as outlined in the protocol will be considered

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Genmab

Last Updated

June 23, 2021