Clinical Trials /

GEN1042 Safety Trial in Subjects With Malignant Solid Tumors

NCT04083599

Description:

To evaluate the safety of GEN1042 in patients with malignant solid tumors

Related Conditions:
  • Colorectal Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: GEN1042 Safety Trial in Subjects With Malignant Solid Tumors
  • Official Title: A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects With Malignant Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: GCT1042-01
  • NCT ID: NCT04083599

Conditions

  • Malignant Solid Tumor
  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • Melanoma

Interventions

DrugSynonymsArms
GEN1042Treatment Administered

Purpose

To evaluate the safety of GEN1042 in patients with malignant solid tumors

Detailed Description

      The trial is an open-label, multi-center, safety trial of GEN1042. The trial consists of two
      parts, a dose escalation (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
Treatment AdministeredExperimentalGEN1042 will be administered every 21 days
  • GEN1042

Eligibility Criteria

        Inclusion Criteria:

        Dose Escalation:

        • Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or
        unresectable and for whom there is no available standard therapy.

        Expansion:

        • Histologically or cytologically confirmed diagnosis of relapsed or refractory, advanced
        and/or metastatic melanoma, NSCLC, or CRC who are not anymore candidates for standard
        therapy

        Dose Escalation and Expansion:

          -  Measurable disease according to RECIST 1.1

          -  Eastern Cooperative Oncology Group (ECOG) 0-1

          -  Acceptable bone marrow and hematological, liver and renal functions

          -  Acceptable coagulation status

        Exclusion Criteria:

        Uncontrolled intercurrent illness, including but not limited to:

          -  Ongoing or active infection treated with intravenous anti-infective therapy less than
             2 weeks prior to first dose

          -  Symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.

          -  Uncontrolled hypertension despite optimal medical management.

          -  Evidence of significant autoimmune disease suggesting risk for immune-related adverse
             events (irAEs).

          -  History of irAEs that led to treatment discontinuation of prior ICP inhibitor

          -  • History of chronic liver disease or evidence of hepatic cirrhosis.

          -  History of non-infectious pneumonitis that 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
             GEN1042.

          -  Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.

          -  Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or
             progressive brain metastases or stroke.

        Prior therapy:

          -  Radiotherapy within 14 days prior to first GEN1042 administration

          -  Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of
             the drug, whichever is shorter), prior to GEN1042 administration.

          -  History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy

          -  Toxicities from previous anti-cancer therapies that have not 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:First Cycle (21 days)
Safety Issue:
Description:Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)

Details

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

Last Updated

May 4, 2020