Status:
COMPLETED
A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114 administered as monotherapy or in combination with selected standard of care (SOC) regimens.
Eligibility Criteria
Inclusion
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent
- Participant has advanced disease (ie, locally advanced or metastatic)
- Participant has measurable or non-measurable disease as defined by the relevant Response Evaluation Criteria in Solid Tumors (RECIST)
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Part A specific:
- \- Participant has a histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, lung adenocarcinoma, lung squamous cell carcinoma, pancreatic adenocarcinoma, prostate adenocarcinoma, stomach adenocarcinoma, bladder urothelial carcinoma, or breast invasive carcinoma
- Part B and C specific:
- \- Participant has a histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction
- Part A1 specific:
- \- Participant has histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction, or pancreatic cancer
Exclusion
- Participant has a known hypersensitivity to any components of the study medications 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
- Symptomatic central nervous system (CNS) malignancy or metastases. Screening of asymptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions prior to study enrolment
- Current hematologic malignancies
- Prior organ or allogeneic stem-cell transplantation
- QT interval corrected (QTc) \>450 msec
- Participant has impaired renal function
- Alanine transaminase or AST are ≥2xULN (if liver metastases are present: ≥5xULN)
- Participant has moderate or severe cardiovascular disease
- Current or chronic history of liver disease or known hepatic or biliary abnormalities other than liver metastases
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04393298
Start Date
July 9 2020
End Date
April 11 2024
Last Update
May 29 2025
Active Locations (9)
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1
Onc001 50414
Los Angeles, California, United States, 90033
2
Onc001 50470
Charleston, South Carolina, United States, 29425
3
Onc001 50471
Houston, Texas, United States, 77030
4
Onc001 40305
Glasgow, United Kingdom