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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: trifluridine/tipiracil; Drug: mFOLFOX6; Drug: ginisortamab

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Onc001 40305
  • London, United Kingdom
    • Onc001 40113
  • Manchester, United Kingdom
    • Onc001 40304
  • Newcastle Upon Tyne, United Kingdom
    • Onc001 40306
  • Oxford, United Kingdom
    • Onc001 40303
  • Sutton, United Kingdom
    • Onc001 40302
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Onc001 50414
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Onc001 50470
  • Texas
    • Houston, Texas, United States, 77030
      • Onc001 50471

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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: ginisortamab; Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.; Other Names: UCB6114
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: 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®; Drug: ginisortamab; Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.; Other Names: UCB6114
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: 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: 5-FU; fluorouracil; Calcium folinate; Drug: ginisortamab; Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.; Other Names: UCB6114
Experimental: Part A1; Study participants will receive predefined doses of UCB6114 as monotherapy administered intravenously at pre-specified time points.	Drug: ginisortamab; Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.; Other Names: UCB6114

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With 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 study medication, whether or not considered related to the study medication. 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 study medication. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date on or after the first dose of UCB6114 up until the last dose of Ginisortamab (UCB6114) +30 days (i.e. up to 3.8 years).	From Baseline until the End of Study (up to 3.8 years)
Percentage of Participants Based on Severity of Treatment-emergent Adverse Events	AE is any untoward medical occurrence in patient or clinical study participant, temporally associated with use of study medication, whether or not considered related to study medication. AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of study medication. TEAE: any AE with start date on or after first dose of UCB6114 up until last dose of Ginisortamab(UCB6114)+30 days. Event for which no Common Terminology Criteria for AE (CTCAE) severity grade was recorded by investigator but intensity was recorded instead was assigned as follows to CTCAE severity grade:Severe=Grade 3, Life Threatening (indicated on electronic case report form (eCRF) for event that is serious)=Grade 4, Death (indicated on the eCRF for event that is serious or has outcome of death)=Grade 5. As planned, data reported for National Cancer Institute (NCI) CTCAE grade >=3 TEAEs and related TEAEs.	From Baseline until the End of Study (up to 3.8 years)
Number of Participants With Dose-limiting Toxicities (DLTs)	DLT defined as any AE at least related to study medication that occurs during Cycle 1 and met following criteria: Grade (Gr) 3 or 4 nonhematological toxicity according to NCI CTCAE (Version 5.0) except for alopecia, or nausea, vomiting, or diarrhea that reverses to Gr ≤2 within 24 hours (hr) with appropriate medical therapy; Gr 3 or 4 biochemical abnormality that persists despite maximal supportive treatment or biochemical abnormalities that is symptomatic and nontransient; Any Gr ≥3 hematological toxicity of >5 days duration or febrile neutropenia (absolute neutrophil count [ANC]<1000/cubic millimeter[mm3] with single temperature of >38.3°C or sustained temperature ≥38°C for more than one hr), infection with Gr 3 or 4 neutropenia, thrombocytopenia with bleeding or requiring platelet transfusion, or Gr 4 thrombocytopenia; Prolonged Gr 2 diarrhea (>7 days) despite adequate antidiarrheal medication, or multiple Grade 1or 2 toxicities(eg, Gr 1 or 2 diarrhea, vomiting, rash, and fatigue).	From Baseline throughout 28 days (Cycle 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort	Blood samples for ginisortamab serum concentration analysis were collected at different timepoints following the first dose of ginisortamab. The data is reported for Part A and A1. Pharmacokinetic Set (PKS). Lower Limit of Quantitation (LLOQ).	Parts A: Cycle 1 (Day 1 end of infusion [EOI] and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose); Part A 1: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose)
Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level	Blood samples for ginisortamab serum concentration analysis were collected at timepoints following (Cycle 1 Day 1) and the (Cycle 2 Day 1) administration of ginisortamab. Data is reported for Part B and Part C.	Part B and C: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Phase 1/2; Advanced solid tumors; UCB6114
• Additional Relevant MeSH Terms: Neoplasms; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Micronutrients; Protective Agents; Antidotes; Vitamin B Complex; Vitamins; Fluorouracil; Leucovorin; Trifluridine
• Other Study ID Numbers: ONC001; 2019-002598-78 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No