A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
NCT ID: NCT06551142
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
590 participants
INTERVENTIONAL
2024-09-30
2027-05-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Dose escalation-GSK5764227 Monotherapy
GSK5764227
GSK5764227 will be administered
Phase 1a- Dose escalation- Combination therapy
GSK5764227
GSK5764227 will be administered
Cisplatin
Cisplatin will be administered
Carboplatin
Carboplatin will be administered
Atezolizumab
Atezolizumab will be administered
Pembrolizumab
Pembrolizumab will be administered
Durvalumab
Durvalumab will be administered
Cetuximab
Cetuximab will be administered
Bevacizumab
Bevacizumab will be administered
Phase 1b- Dose optimisation/ expansion
GSK5764227
GSK5764227 will be administered
Atezolizumab
Atezolizumab will be administered
Interventions
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GSK5764227
GSK5764227 will be administered
Cisplatin
Cisplatin will be administered
Carboplatin
Carboplatin will be administered
Atezolizumab
Atezolizumab will be administered
Pembrolizumab
Pembrolizumab will be administered
Durvalumab
Durvalumab will be administered
Cetuximab
Cetuximab will be administered
Bevacizumab
Bevacizumab will be administered
Eligibility Criteria
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Inclusion Criteria
* Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows:
o Phase 1a:
* Participants with advanced/metastatic solid tumors.
* For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.
* 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. Tumor tissue is necessary for retrospective detection of B7 homolog 3 protein (B7-H3) expression by Immunohistochemistry (IHC) and other biomarker analysis.
* At least one of the following treatment combinations/monotherapy (a, b, c, or d) is clinically indicated:
1. Atezolizumab, durvalumab, or pembrolizumab in combination with cisplatin or carboplatin (for combination 1 only).
2. Atezolizumab, durvalumab, or pembrolizumab as monotherapy (for combination 2 only)
3. Bevacizumab as monotherapy (for combination 3 only)
4. Cetuximab as monotherapy (for combination 4 only)
Chinese participants are considered eligible if they meet all of the following:
* Born in mainland China, Hong Kong or Taiwan
* Descendant of 2 ethnic Chinese parents and 4 ethnic Chinese grandparents
Exclusion Criteria
* 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:
* Has QT interval, corrected for heart rate (QTc) \>450 msec or QTc \>480 msec for participants with bundle branch block.
* 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).
* 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.
* 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 Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
* Has donated blood or blood products in excess of 500 mL (approximately 1 pint) within one month prior to first dose of study treatment.
* 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 immunosuppressive agents within 30 days prior to first dose of study treatment (or requires long-term (30 days or longer) glucocorticoid therapy). Low-dose corticosteroids (prednisone ≤10 mg/day or equivalent) may be administered. Use of inhaled or topical steroids and prophylactic corticosteroids for procedures are permitted.
* Participants in dehydrated condition.
* Participant with history of nephrotic syndrome or Grade 3 proteinuria. Participants discovered to have ≥2 proteinuria on dipstick at screening should undergo a 24-hour urine collection and must demonstrate \<2 g of protein in 24 hours to be eligible.
* History of abdominal or gastrointestinal fistula, tracheoesophageal fistula or any Grade 4 fistula, gastrointestinal perforation, intra-abdominal abscess or active clinical concern for bowel obstruction.
* Has any active renal condition (e.g., requirement for dialysis, or any other significant renal condition that could affect the participant's safety). NOTE: renal obstruction successfully managed by stenting is permitted.
* Has received prior systemic anticancer therapy within 28 days of first dose of study treatment (combinations 1, 3 and 4 only).
* Has experienced any of the following with prior immunotherapy: any immune-mediated adverse event \[imAE\] ≥ Grade 3, immune-mediated severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson syndrome \[SJS\], Toxic epidermal necrolysis \[TEN\], or Drug reaction with eosinophilia and systemic symptoms \[DRESS\] syndrome), symptomatic pericarditis of any etiology within 6 months prior to the administration of study intervention, or myocarditis of any grade. Clinically significant laboratory abnormalities, as judged by investigator, are not exclusionary.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Stanford, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
New Brunswick, New Jersey, United States
GSK Investigational Site
Myrtle Beach, South Carolina, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Tyler, Texas, United States
GSK Investigational Site
West Valley City, Utah, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Viedma, , Argentina
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Bordeaux, , France
GSK Investigational Site
Lyon, , France
GSK Investigational Site
Villejuif, , France
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Napoli, , Italy
GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Chiba, , Japan
GSK Investigational Site
Shizuoka, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Gyeonggi-do, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
Changhua, , Taiwan
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Tainan, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Edinburgh, , United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
Countries
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Central Contacts
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EU GSK Clinical Trials Call Center
Role: CONTACT
Phone: +44 (0) 20 89904466
Email: [email protected]
Facility Contacts
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US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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US GSK Clinical Trials Call Center
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EU GSK Clinical Trials Call Centre
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US GSK Clinical Trials Call Center
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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US GSK Clinical Trials Call Center
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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EU GSK Clinical Trials Call Centre
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Other Identifiers
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2024-513663-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
223054
Identifier Type: -
Identifier Source: org_study_id