Clinical trial NCT04393298: A Study to Assess the Safety, Pharmacokinetics and Anti Tumor 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 Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumors
UCB6114
Phase 1/2
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Modular design, escalation \& expansion modules. Depending on emerging data, not all modules may open
Primary purpose: TREATMENT

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.


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

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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline until the End of Study (up to 3.8 years)
measure: Percentage of Participants Based on Severity of Treatment-emergent Adverse Events
timeFrame: From Baseline until the End of Study (up to 3.8 years)
measure: Number of Participants With Dose-limiting Toxicities (DLTs)
timeFrame: From Baseline throughout 28 days (Cycle 1)
Secondary outcomes:
measure: Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort
timeFrame: 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)
measure: Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level
timeFrame: Part B and C: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Onc001 50414
state: California
city: Charleston
country: United States
facility: Onc001 50470
state: South Carolina
city: Houston
country: United States
facility: Onc001 50471
state: Texas
city: Glasgow
country: United Kingdom
facility: Onc001 40305
city: London
country: United Kingdom
facility: Onc001 40113
city: Manchester
country: United Kingdom
facility: Onc001 40304
city: Newcastle Upon Tyne
country: United Kingdom
facility: Onc001 40306
city: Oxford
country: United Kingdom
facility: Onc001 40303
city: Sutton
country: United Kingdom
facility: Onc001 40302
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: