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Monoclonal Antibodies

UCB6114 for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has advanced disease (ie, locally advanced or metastatic)
Participant must be at least 18 years of age inclusive, at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline throughout 28 days (cycle 1)
Awards & highlights

Study Summary

This trial is testing a new experimental drug, UCB6114, to see if it is safe and effective when used alone or with other standard cancer treatments.

Who is the study for?
Adults with certain advanced solid tumors, including various adenocarcinomas and squamous cell carcinomas. Participants must have a performance status indicating they are relatively active and well. Exclusions include hypersensitivity to study drugs, blood cancers, organ transplants, heart disease, liver disease beyond metastases, significant infections or HIV/AIDS.Check my eligibility
What is being tested?
The trial is testing UCB6114 alone or with standard treatments (trifluridine/tipiracil or mFOLFOX6) for safety and how the body processes it. It's aimed at adults with specific advanced solid tumors to see if these combinations can shrink or control tumor growth.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to ginisortamab; trifluridine/tipiracil could cause fatigue and digestive issues; mFOLFOX6 might lead to nerve damage, nausea, and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread beyond its original location.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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I have been diagnosed with advanced colorectal, gastric, or gastroesophageal junction cancer.
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I have been diagnosed with a specific type of advanced cancer.
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I have been diagnosed with a specific type of advanced cancer in the colon, stomach, gastroesophageal junction, or pancreas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline throughout 28 days (cycle 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline throughout 28 days (cycle 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Incidence of treatment-emergent adverse events (TEAEs)
Severity of TEAEs
Secondary outcome measures
UCB6114 concentration by scheduled assessment and cohort for Part A and A1
UCB6114 concentration by scheduled assessment and dose level for Part B and C

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part CExperimental Treatment2 Interventions
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.
Group II: Part BExperimental Treatment2 Interventions
Study participants assigned to this arm will receive UCB6114 in escalating cohorts at pre-specified dose levels in combination with trifluridine/tipiracil (TFD/TPI).
Group III: Part A1Experimental Treatment1 Intervention
Study participants will receive predefined doses of UCB6114 as monotherapy administered intravenously at pre-specified time points.
Group IV: Part AExperimental Treatment1 Intervention
Study participants assigned this arm will receive UCB6114 as monotherapy in escalating cohorts at pre-specified dose levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
trifluridine/tipiracil
2017
Completed Phase 1
~10
mFOLFOX6
2009
Completed Phase 4
~1400

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,341 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,868 Total Patients Enrolled

Media Library

UCB6114 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04393298 — Phase 1 & 2
Solid Tumors Research Study Groups: Part A1, Part B, Part C, Part A
Solid Tumors Clinical Trial 2023: UCB6114 Highlights & Side Effects. Trial Name: NCT04393298 — Phase 1 & 2
UCB6114 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04393298 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available enrollments for this research trial?

"According to the clinicaltrials.gov listing, this research project is currently open for participant enrollment. It was initially published on July 9th 2020 and recently revised on November 4th 2022."

Answered by AI

What other studies have been conducted with UCB6114 as the primary focus?

"Currently, 424 clinical trials are actively studying UCB6114 with 131 of those studies in Phase 3. Most of these experiments are located within New york City, yet a collective 22020 sites globally have registered to run tests on this agent."

Answered by AI

How extensive is the current population participating in this medical experiment?

"Affirmative. The clinicaltrial.gov website indicates that this trial is still recruiting participants, having been initially posted in July 2020 and updated as recently as November 2022. 240 individuals are needed across 5 separate research sites to complete the study."

Answered by AI

What is the typical purpose for the administration of UCB6114?

"UCB6114 is a common drug used to alleviate rectal carcinoma. Additionally, it may be prescribed for advanced esophageal cancers, folate deficiency anemia and metastatic colorectal cancer (crc)."

Answered by AI

On what scale is this clinical research being conducted across health facilities?

"Five distinct trial sites have been established for this medical research including Onc001 50470 in Charleston, Onc001 50414 in Newport Beach, and Onc001 50471 in Houston. An additional five locations are also operating."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors
2020. "A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04393298.
~0 spots leftby May 2024
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