What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as gemcitabine, nabpaclitaxel, and temozolomide, are associated with several side effects. Gemcitabine and nabpaclitaxel can cause neutropenia, fatigue, neuropathy, and diarrhea. Temozolomide is linked to hematologic toxicities, including myelodysplastic syndrome, and liver injury. These side effects are crucial in evaluating the safety and pharmacokinetics of new treatments like UCB6114.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of advanced solid tumors, focusing on their safety and pharmacokinetics. Pembrolizumab, an immune checkpoint inhibitor, has been approved for various solid tumors, including non-small cell lung cancer and melanoma, based on its efficacy and safety profile demonstrated in trials like KEYNOTE-189 and KEYNOTE-006. Atezolizumab, another immune checkpoint inhibitor, has been approved for non-small cell lung cancer and renal cell carcinoma, with studies such as IMpower150 and IMmotion151 supporting its use. These approvals highlight the importance of comprehensive safety and pharmacokinetic evaluations in the development of new cancer therapies.

What other types of research exist?

Promising novel alternatives to UCB6114 for solid tumor patients include pembrolizumab (Keytruda) in combination with chemotherapy, as demonstrated in the KEYNOTE-189 trial for non-small cell lung cancer, and cabozantinib (Cabometyx), which has shown efficacy in medullary thyroid cancer and renal cell carcinoma. Additionally, rucaparib (Rubraca) and niraparib (Zejula) are promising for prostate cancer with homologous recombination repair deficiency. These therapies have shown significant anti-tumor activity and are supported by robust clinical trial data.

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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

Must not have

Current or chronic history of liver disease or known hepatic or biliary abnormalities other than liver metastases

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline throughout 28 days (cycle 1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called UCB6114 to see if it is safe and how it behaves in the body. It will be given alone or with other standard treatments to patients. The study focuses on understanding its safety and effects.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of liver disease, except for liver metastases.

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I do not have any active serious infections or known HIV/AIDS.

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I have a serious heart condition.

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My kidneys are not working properly.

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I have a blood cancer.

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I have had an organ or stem-cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline throughout 28 days (cycle 1)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicities (DLTs)

Incidence of treatment-emergent adverse events (TEAEs)

Severity of TEAEs

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

mFOLFOX6

2009

Completed Phase 4

~1600

ginisortamab

2020

Completed Phase 2

~100

trifluridine/tipiracil

2017

Completed Phase 2

~110

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways essential for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. These mechanisms are vital for solid tumor patients as they offer multiple strategies to control tumor progression, improve quality of life, and potentially extend survival.

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