Advanced solid tumors
Conditions
Interventions
Product Code: UCB6114
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: UCB6114
Other descriptive name: UCB6114
Concentration unit: mg/ml milligram(s)
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Characterize the safety profile of UCB6114;Secondary Objective: Characterize the pharmacokinetics (PK) of UCB6114;Primary end point(s): 1. Incidence of dose-limiting toxicities (DLTs) 2. Incidence of treatment-emergent adverse events (TEAEs) 3. Severity of TEAEs;Timepoint(s) of evaluation of this end point: 1. From Baseline throughout 28 days (Cycle 1) 2. and 3. From Baseline through study completion, an average of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): UCB6114 concentration by time and dose;Timepoint(s) of evaluation of this end point: From Baseline through study completion, an average of 12 weeks | — |
Countries
United Kingdom
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed