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Looking for participantsPhase1

A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)

Sponsor: GlaxoSmithKline

NCT ID: NCT06551142

View on ClinicalTrials.gov ↗

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

Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

PR

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
Inclusion criteria * Male or female participants at least 18 years of age (≥18 years) * Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows: Phase 1a: 1. Participants with advanced/metastatic solid tumors. 2. For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies. 3. For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. * Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose. * Has adequate organ function. * Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing. Exclusion criteria * Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy. * Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents. * Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not). * Any of the following cardiac examination abnormality: 1. Has QT interval, corrected for heart rate (QTc) \>450 msec or QTc \>480 msec for participants with bundle branch block. 2. Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular \[AV\] block, second-degree AV block, PR interval \>250 msec). 3. Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval. 4. Left ventricular ejection fraction (LVEF) \<50%. * Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events * Participants with evidence of current ILD/non-infectious pneumonitis OR a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging. * Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary). * Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. * Has received prior anticancer therapy within 28 days of the first dose of study intervention or having to continue these medications during the study.

Where Is This Study? (6 UK sites)

GSK Investigational Site

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Stefan SymeonidesPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Jeff EvansPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London W1G 6AD, United Kingdom

Recruiting
Site contact (verified)
Anja WilliamsPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London WC1E 6AG, United Kingdom

Recruiting
Site contact (verified)
Sarah BenafifPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Fiona ThistlethwaitePrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Christoph OingPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05