Clinical Trials /

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

NCT04393298

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Bladder Urothelial Carcinoma
  • Colorectal Adenocarcinoma
  • Esophageal Carcinoma
  • Gastric Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Invasive Breast Carcinoma
  • Lung Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Prostate Adenocarcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ONC001
  • SECONDARY ID: 2019-002598-78
  • NCT ID: NCT04393298

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
UCB6114Part A
trifluridine/tipiracilTAS-102, Lonsurf®Part B
mFOLFOX6Calcium folinate, 5-FU, fluorouracilPart C

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part AExperimentalStudy participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels.
  • UCB6114
Part BExperimentalStudy participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI).
  • UCB6114
  • trifluridine/tipiracil
Part CExperimentalStudy 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.
  • UCB6114
  • mFOLFOX6

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UCB Biopharma SRL

Trial Keywords

  • Advanced solid tumors
  • UCB6114
  • Phase 1/2

Last Updated

August 13, 2021