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A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

NCT04393298

Description:

The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
  • Official Title: A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: ONC001
  • SECONDARY ID: 2019-002598-78
  • NCT ID: NCT04393298

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
UCB6114UCB6114 iv infusion

Purpose

The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114.

Trial Arms

NameTypeDescriptionInterventions
UCB6114 iv infusionExperimentalStudy participants assigned this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels.
  • UCB6114

Eligibility Criteria

        Inclusion Criteria:

        Participants are eligible to be included in the escalation module of the study only if all
        of the following criteria apply:

          -  Participant must be at least 18 years of age inclusive, at the time of signing the
             informed consent

          -  Participant has a histologically and/or cytologically confirmed diagnosis of one of
             the selected advanced solid tumor types

          -  Participant has advanced disease (ie, locally recurrent or metastatic) and had access
             to approved therapies

        Exclusion Criteria:

        Participants are excluded from the escalation module of the study if any of the following
        criteria apply:

          -  Participant has any medical or psychiatric condition that, in the opinion of the
             investigator, could jeopardize or would compromise the study participant's ability to
             participate in this study

          -  Participant has a history of severe allergic, anaphylactic, or other hypersensitivity
             reactions

          -  Participant has a known hypersensitivity to any components of the study medication or
             comparable drugs

          -  Active and clinically significant bacterial, fungal, or viral infection, known
             infections with hepatitis B, hepatitis C, known human immunodeficiency virus, or
             acquired immunodeficiency syndrome related illness

          -  Chronic underlying infection or disease that, in the view of the investigator, should
             preclude the participant from enrolling in the study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities (DLTs)
Time Frame:From Baseline throughout 28 days (Cycle 1)
Safety Issue:
Description:Dose-limiting toxicity is defined as any adverse event at least possibly related to UCB6114, and meeting specified DLT criteria.

Secondary Outcome Measures

Measure:UCB6114 concentration by time and dose
Time Frame:From Baseline through study completion, an average of 12 weeks
Safety Issue:
Description:Blood samples will be taken at selected times throughout the study to determine UCB6114 concentration following study drug administration.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UCB Biopharma S.P.R.L.

Trial Keywords

  • Advanced solid tumors
  • UCB6114
  • Phase 1/2

Last Updated

July 17, 2020