A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393298
• Other study ID #: ONC001
• Secondary ID: 2019-002598-78
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 9, 2020
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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:

• 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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United Kingdom	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 States	Onc001 50470	Charleston	South Carolina
United States	Onc001 50471	Houston	Texas
United States	Onc001 50414	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs)	Dose-limiting toxicity is defined as any adverse event at least possibly related to UCB6114, and meeting specified DLT criteria.	From Baseline throughout 28 days (Cycle 1)
Primary	Incidence of treatment-emergent adverse events (TEAEs)	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.	From Baseline through study completion, an average of 12 weeks
Primary	Severity of TEAEs	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.	From Baseline through study completion, an average of 12 weeks
Secondary	UCB6114 concentration by scheduled assessment and cohort for Part A and A1	Blood samples will be taken at selected times throughout the study to determine UCB6114 concentration following study drug administration.	From Baseline through study completion, an average of 12 weeks
Secondary	UCB6114 concentration by scheduled assessment and dose level for Part B and C	Blood samples will be taken at selected times throughout the study to determine UCB6114 concentration following study drug administration.	From Baseline through study completion, an average of 12 weeks