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

  • STATUS
    Recruiting
  • participants needed
    222
  • sponsor
    UCB Biopharma S.P.R.L.
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Updated on 19 February 2024
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Summary

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

Details
Condition Advanced Solid Tumors
Age 18years - 100years
Treatment UCB6114
Clinical Study IdentifierNCT04393298
SponsorUCB Biopharma S.P.R.L.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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