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

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ClinicalTrials.gov Identifier: NCT04393298
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: UCB6114 Drug: trifluridine/tipiracil Drug: mFOLFOX6 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Modular design, escalation & expansion modules. Depending on emerging data, not all modules may open
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : September 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
Study participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels.
 Drug: UCB6114
Study participants will receive predefined doses of UCB6114 administered intravenously at pre-specified time points.
Experimental: 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).
 Drug: UCB6114
Study participants will receive predefined doses of UCB6114 administered intravenously at pre-specified time points.

Drug: trifluridine/tipiracil
Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.
Other Names:
  • TAS-102
  • Lonsurf®
Experimental: 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.
 Drug: UCB6114
Study participants will receive predefined doses of UCB6114 administered intravenously at pre-specified time points.

Drug: 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 Names:
  • Calcium folinate
  • 5-FU
  • fluorouracil


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 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.

  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 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.

  3. Severity of TEAEs [ Time Frame: 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 :
  1. UCB6114 concentration by scheduled assessment and dose level [ Time Frame: 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. The mean UCB6114 concentration by dose level will be disclosed as pre-specified in the protocol.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393298


Contacts
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Contact: UCB Cares 1-844-599-2273 (USA) UCBCares@ucb.com
Contact: UCB Cares 001 844 599 2273 UCBCares@ucb.com

Locations
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United States, California
Onc001 50414 Recruiting
Los Angeles, California, United States, 90033
Onc001 50502 Recruiting
Newport Beach, California, United States, 92663
United States, South Carolina
Onc001 50470 Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Onc001 50471 Recruiting
Houston, Texas, United States, 77030
United Kingdom
Onc001 40305 Recruiting
Glasgow, United Kingdom
Onc001 40113 Recruiting
London, United Kingdom
Onc001 40304 Recruiting
Manchester, United Kingdom
Onc001 40306 Recruiting
Newcastle Upon Tyne, United Kingdom
Onc001 40303 Recruiting
Oxford, United Kingdom
Onc001 40302 Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273
More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04393298    
Other Study ID Numbers: ONC001
2019-002598-78 ( EudraCT Number )
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
URL: https://www.Vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Advanced solid tumors
UCB6114
Phase 1/2
Additional relevant MeSH terms:
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Neoplasms
Leucovorin
Trifluridine
Fluorouracil
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
 Immunosuppressive Agents
Immunologic Factors
Antiviral Agents
Anti-Infective Agents
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients