A study to assess the safety, pharmacokinetics and anti tumor activity of UCB6114 administered intravenously to participants with advanced solid tumors

Phase 1

• Conditions: Advanced solid tumors; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002598-78-GB
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 222

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 178
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified