Description:
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.
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.
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
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UCB6114 | Part A | |
trifluridine/tipiracil | TAS-102, Lonsurf® | Part B |
mFOLFOX6 | Calcium folinate, 5-FU, fluorouracil | Part C |
Name | Type | Description | Interventions |
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Part A | Experimental | Study participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels. |
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Part B | Experimental | Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI). |
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Part C | Experimental | 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. |
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Inclusion Criteria: - 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 Exclusion Criteria: - 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 symptomatic 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 for male participants or QTc >470 msec for female participants or QTc >480 msec in participants with bundle branch block - 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Incidence of dose-limiting toxicities (DLTs) |
Time Frame: | From Baseline throughout 28 days (Cycle 1) |
Safety Issue: | |
Description: | Dose-limiting toxicity is defined as any adverse event at least possibly related to UCB6114, and meeting specified DLT criteria. |
Measure: | UCB6114 concentration by scheduled assessment and dose level |
Time Frame: | From Baseline through study completion, an average of 12 weeks |
Safety Issue: | |
Description: | Blood samples will be taken at selected times throughout the study to determine UCB6114 concentration following study drug administration. The mean UCB6114 concentration by dose level will be disclosed as pre-specified in the protocol. |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | UCB Biopharma SRL |
August 13, 2021