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

UCB

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: ginisortamab; Drug: mFOLFOX6; Drug: trifluridine/tipiracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT04393298

ONC001

2019-002598-78 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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93 participants in 4 patient groups

Part A

Experimental group

Description:

Study participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels.

Treatment:

Drug: ginisortamab

Part A1

Experimental group

Description:

Study participants will receive predefined doses of UCB6114 as monotherapy administered intravenously at pre-specified time points.

Treatment:

Drug: ginisortamab

Part B

Experimental group

Description:

Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI).

Treatment:

Drug: trifluridine/tipiracil

Drug: ginisortamab

Part C

Experimental group

Description:

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.

Treatment:

Drug: mFOLFOX6

Drug: ginisortamab