A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT04393298
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B trifluridine/tipiracil Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI). Part C mFOLFOX6 Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) regimen. Part A ginisortamab Study participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels. Part B ginisortamab Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI). Part C ginisortamab Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) regimen. Part A1 ginisortamab Study participants will receive predefined doses of UCB6114 as monotherapy administered intravenously at pre-specified time points.
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) From Baseline throughout 28 days (Cycle 1) Dose-limiting toxicity is defined as any adverse event at least possibly related to UCB6114, and meeting specified DLT criteria.
Incidence of treatment-emergent adverse events (TEAEs) From Baseline through study completion, an average of 12 weeks An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Severity of TEAEs From Baseline through study completion, an average of 12 weeks An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
- Secondary Outcome Measures
Name Time Method UCB6114 concentration by scheduled assessment and cohort for Part A and A1 From Baseline through study completion, an average of 12 weeks Blood samples will be taken at selected times throughout the study to determine UCB6114 concentration following study drug administration.
UCB6114 concentration by scheduled assessment and dose level for Part B and C From Baseline through study completion, an average of 12 weeks Blood samples will be taken at selected times throughout the study to determine UCB6114 concentration following study drug administration.
Trial Locations
- Locations (9)
Onc001 50414
🇺🇸Los Angeles, California, United States
Onc001 40304
🇬🇧Manchester, United Kingdom
Onc001 40305
🇬🇧Glasgow, United Kingdom
Onc001 40113
🇬🇧London, United Kingdom
Onc001 40306
🇬🇧Newcastle Upon Tyne, United Kingdom
Onc001 40303
🇬🇧Oxford, United Kingdom
Onc001 40302
🇬🇧Sutton, United Kingdom
Onc001 50470
🇺🇸Charleston, South Carolina, United States
Onc001 50471
🇺🇸Houston, Texas, United States