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
- Ris-Rez (biological), Cisplatin (drug), Carboplatin (drug), Atezolizumab (biological)
- How long the study runs
- Study runs about 57 months (dates as stated)
- About the drug or intervention
- Ris-Rez — biological: Ris-Rez will be administered · Cisplatin — drug: Cisplatin will be administered · Carboplatin — drug: Carboplatin will be administered · Atezolizumab — biological: Atezolizumab will be administered · Pembrolizumab — biological: Pembrolizumab will be administered · Durvalumab — biological: Durvalumab will be administered · Cetuximab — biological: Cetuximab will be administered · Bevacizumab — biological: Bevacizumab will be administered · Tarlatamab — biological: Tarlatamab will be administered · Dostarlimab — biological: Dostarlimab will be administered
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called EMBOLD, is testing a new drug called GSK5764227 in adults aged 18 or over with advanced or spread solid tumours (cancer growths). It is run by GlaxoSmithKline. Phase 1a of the study looks at the drug on its own and in combination with other medicines, in people whose cancer has either not responded to standard treatments or who have had a limited number of previous treatments.
Who can take part
- Adults aged 18 or over, male or female.
- Confirmed advanced or spread (metastatic) solid tumours, based on laboratory testing of tissue.
- For the part testing the drug alone: your cancer has got worse on, or you could not tolerate, all available standard treatments.
- For the part testing the drug in combination: you have had 3 or fewer previous courses of systemic anti-cancer treatment (medicine that travels through the whole body) for advanced or spread cancer.
- At least 1 tumour that can be measured on a scan (known as a target lesion).
- Good day-to-day functioning (performance status of 0 or 1), with no decline in the 2 weeks before the first dose.
- Organs such as the liver and kidneys working well enough.
- Where possible, providing a stored tumour sample from a recent biopsy for central testing.
Who may not be able to
- Ongoing side effects from previous treatment that have not settled down (recovered to mild level or back to how you were before).
- Previous treatment with orlotamab, enoblituzumab, I-Dxd, or other drugs targeting B7-H3.
- A primary brain tumour or cancer spread to the brain, unless specific conditions are met (for example: no symptoms, stable for at least 4 weeks, no steroid treatment for at least 4 weeks, and no pressure on the middle of the brain). Also excluded: worsening untreated brain disease, involvement of the lining of the brain or brainstem, or spinal cord compression.
- Certain heart findings, such as a corrected QT interval (a heart-rhythm measurement on an ECG) over 450 milliseconds, or over 480 milliseconds if you have bundle branch block.
- Significant abnormal heart rhythms or ECG changes, such as complete left bundle branch block, second- or third-degree heart block, or a PR interval over 250 milliseconds.
- Risk factors for heart-rhythm problems, such as heart failure, long-term low potassium, long QT syndrome (including family history), unexplained sudden death of a close relative under 40, or taking medicines that prolong the QT interval.
- The heart's pumping strength (left ventricular ejection fraction) below 50%.
- Severe, uncontrolled or active heart or blood vessel problems, badly controlled high blood pressure, significant bleeding, or serious blood clots in arteries or veins.
- Current or past inflammation or scarring of the lungs (interstitial lung disease or non-infectious pneumonitis), or suspicion of it that cannot be ruled out by scans.
- Autoimmune disease needing whole-body (systemic) treatment in the past 2 years. Simple replacement medicines, such as thyroid hormone or insulin, do not count.
- Any past bone marrow transplant (from your own cells or a donor) or other solid organ transplant.
- Anti-cancer treatment within 28 days of the first study dose, or needing to keep taking it during the study.
What taking part involves
- • Taking the study drug GSK5764227 on its own (monotherapy dose escalation).
- • Or taking GSK5764227 in combination with other medicines (combination dose escalation).
- • The exact way the drug is given and what it is combined with — Not stated — ask the trial team.
Time commitment: Details such as how long the study lasts, how often you attend visits, and how the drug is given are Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 845
- Started
- 2024-09-30
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for neoplasms
- • Phase1 - 845 participants
- • The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with neoplasms
Where?
- • Edinburgh - GSK Investigational Site
- • Glasgow - GSK Investigational Site
- • London - GSK Investigational Site
- • London - GSK Investigational Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab
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
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ progressed on or become intolerant to all available SOC therapies
- ✓ received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting
- ✓ that has(have) not recovered to ≤Grade 1
- ✓ orlotamab
What the study is looking for
- ✓Inclusion criteria
- ✓Male or female participants at least 18 years of age (≥18 years)
- ✓Participants with confirmed by a biopsy advanced/that has spread solid tumors, as defined per study phase and cohort,...
- ✓Phase 1a:
- ✓Participants with advanced/that has spread solid tumors.
See the full criteria
Where Is This Study? (6 UK sites)
GSK Investigational Site
Edinburgh EH4 2XU, United Kingdom
GSK Investigational Site
Glasgow G12 0YN, United Kingdom
GSK Investigational Site
London W1G 6AD, United Kingdom
GSK Investigational Site
London WC1E 6AG, United Kingdom
GSK Investigational Site
Manchester M20 4BX, United Kingdom
GSK Investigational Site
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
