A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
NCT ID: NCT04393298
Last Updated: 2025-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
93 participants
INTERVENTIONAL
2020-07-09
2024-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A
Study participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels.
ginisortamab
Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
Part A1
Study participants will receive predefined doses of UCB6114 as monotherapy administered intravenously at pre-specified time points.
ginisortamab
Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
Part B
Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI).
ginisortamab
Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
trifluridine/tipiracil
Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.
Part C
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.
ginisortamab
Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
mFOLFOX6
Study participants will receive predefined doses of oxaliplatin, Leucovorin and 5-fluorouracil as part of the mFOLFOX6 chemotherapy regimen administered as intravenous (iv) infusion at prespecified time points.
Interventions
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ginisortamab
Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
trifluridine/tipiracil
Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.
mFOLFOX6
Study participants will receive predefined doses of oxaliplatin, Leucovorin and 5-fluorouracil as part of the mFOLFOX6 chemotherapy regimen administered as intravenous (iv) infusion at prespecified time points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Onc001 50414
Los Angeles, California, United States
Onc001 50470
Charleston, South Carolina, United States
Onc001 50471
Houston, Texas, United States
Onc001 40305
Glasgow, , United Kingdom
Onc001 40113
London, , United Kingdom
Onc001 40304
Manchester, , United Kingdom
Onc001 40306
Newcastle upon Tyne, , United Kingdom
Onc001 40303
Oxford, , United Kingdom
Onc001 40302
Sutton, , United Kingdom
Countries
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References
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Davies GCG, Dedi N, Jones PS, Kevorkian L, McMillan D, Ottone C, Schulze MED, Scott-Tucker A, Tewari R, West S, Wright M, Rowley TF. Discovery of ginisortamab, a potent and novel anti-gremlin-1 antibody in clinical development for the treatment of cancer. MAbs. 2023 Jan-Dec;15(1):2289681. doi: 10.1080/19420862.2023.2289681. Epub 2023 Dec 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002598-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ONC001
Identifier Type: -
Identifier Source: org_study_id
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