At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- XB010 (drug), Pembrolizumab (drug)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- XB010 — drug: IV administration of XB010 · Pembrolizumab — drug: IV administration of Pembrolizumab
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 396
- Started
- 2024-08-06
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for locally advanced or metastatic solid tumors
- • Phase1 - 396 participants
- • This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with locally advanced or metastatic solid tumors
Where?
- • Leicester - University Hospitals of Leicester NHS Trust
- • London - Sarah Cannon Research Institute London
- • London - University College London Hospitals NHS Foundation Trust
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.
More detail
This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ signed the informed consent document
What the study is looking for
- ✓Age 18 years or older on the day of consent.
- ✓activity scale (ECOG) Performance Status of 0-1.
- ✓Adequate organ and marrow function.
- ✓Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, that has grown locally,...
- ✓Capable of understanding and complying with the protocol requirements and must have signed the agreement to take part...
See the full criteria
Where Is This Study? (4 UK sites)
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Sarah Cannon Research Institute London
London W1G 6AD, United Kingdom
University College London Hospitals NHS Foundation Trust
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Exelixis Clinical Trials
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