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Completed

NCT Number: NCT04393298

A 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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Onc001 40305, Glasgow, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ginisortamab

Drug

Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.

Other names: UCB6114

Trifluridine/tipiracil

Drug

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®

mFOLFOX6

Drug

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

Primary outcomes

  1. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: From Baseline until the End of Study (up to 3.8 years)

    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).

  2. Percentage of Participants Based on Severity of Treatment-emergent Adverse Events

    Time frame: From Baseline until the End of Study (up to 3.8 years)

    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.

  3. Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: From Baseline throughout 28 days (Cycle 1)

    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).

Secondary outcomes

  1. Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort

    Time frame: 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)

    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).

  2. Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level

    Time frame: Part B and C: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose)

    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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 19, 2020
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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