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New treatment option for Advanced Solid Tumours
Official title A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer
ClinicalTrials.gov ID: NCT06380816
What this study is testing
What is UCB4594?
UCB4594 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up
- Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or...
- Measurable disease, according to RECIST v1.1
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group performance status of 0 or 1
You likely can't join if
- Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other...
- Ongoing toxicity of previous treatments \>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement...
- Patients with rapidly progressing / symptomatically deteriorating brain/leptomeningeal metastases/untreated brain metastases are excluded. Patients...
- Pregnant or breastfeeding female patients (or planning to breastfeed)
- Women of childbearing potential. However, those not already pregnant or breastfeeding (or who discontinue breastfeeding) and meet the following are...
- Male patients with partners of childbearing potential. However, patients who meet the following are eligible: 6.1. Agree to a barrier method of...
See the full eligibility criteria
- Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up
- Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the...
- Measurable disease, according to RECIST v1.1
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's eligibility to participate in the trial
- Aged 18 years or over at the time consent is given. Participants aged 16-17 years may be eligible for recruitment to the backfill cohorts in dose escalation once adequate safety and toxicity data have been established...
- Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other IMPs during the previous 4 weeks or 5 half-lives (whichever is...
- Ongoing toxicity of previous treatments \>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement therapy (HRT)-managed endocrine disorders)
- Patients with rapidly progressing / symptomatically deteriorating brain/leptomeningeal metastases/untreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't...
- Pregnant or breastfeeding female patients (or planning to breastfeed)
- Women of childbearing potential. However, those not already pregnant or breastfeeding (or who discontinue breastfeeding) and meet the following are eligible: 5.1. Have a negative serum pregnancy test within 7 days...
- Male patients with partners of childbearing potential. However, patients who meet the following are eligible: 6.1. Agree to a barrier method of contraception or sexual abstinence 6.2. Males with pregnant or...
- Surgery from which the patient has not yet recovered
- High medical risk because of non-malignant systemic disease, including serious or uncontrolled infection (requiring intravenous antibiotics) or unexplained fever \>38°C within 2 weeks prior to the first dose of UCB4594
- Known to be serologically positive for hepatitis B virus, hepatitis C virus or human immunodeficiency virus
- Active or suspected autoimmune disease, or any history of autoimmune condition that required systemic corticosteroids or immunosuppressive agents. Patients who have ever had a transplant are excluded. This does not...
- Are being treated with escalating or supraphysiologic doses of corticosteroids or immunosuppressive agents. Participants with immunotherapy-related hypophysitis adequately treated with physiologic doses of steroids are...
- Hypersensitivity to the ingredients/excipients (including polysorbate 80) in UCB4594
- History of significant toxicities from treatment of immune checkpoint inhibitors (CPIs) that necessitated permanent discontinuation (Patients who started on combination CPI [e.g., ipilimumab/nivolumab] and had toxicity...
- History of Grade ≥3 infusion-related reaction to monoclonal antibodies or similar drugs
- Prior treatment with HLA-G, immunoglobulin-like transcript (ILT)2 or ILT4-targeting drug
- Live, attenuated vaccine within 28 days prior to the first dose of IMP
- Increased risk due to tumour flare (e.g., an initial increase in tumour size that may lead to obstruction of airways, etc)
- Significant active pulmonary disease or condition at screening, including: 18.1. Lymphangitis carcinomatosa 18.2. History of interstitial lung disease or pulmonary fibrosis 18.3. History of pulmonary inflammatory disease
- Evidence of bleeding diathesis
- Significant cardiovascular disease, defined as a history of: congestive heart failure requiring therapy or left ventricular ejection fraction \ 450 msec for males and \>470 msec for females on triplicate...
- Participant in or plans to join another treatment trial
- Other current malignancies. Cancer survivors who have undergone potentially curative therapy for prior malignancy with no evidence of disease for 3+ years are eligible
- Any other condition that, in the Investigator's opinion, means the trial is not in the patient's best interest
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom; Manchester, United Kingdom; Newcastle upon Tyne, United Kingdom; Southampton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.