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Testing GSK5764227 in patients with advanced solid tumors

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

Phase 1 Interventional GlaxoSmithKline · NCT06551142

This study is testing a new cancer drug called GSK5764227 to see if it is safe and effective for people with advanced solid tumors, both on its own and with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment590 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Drugs / interventionsAtezolizumab, durvalumab, pembrolizumab, Bevacizumab, Cetuximab, orlotamab, enoblituzumab, immunotherapy, prednisone
Locations53 sites (Stanford, California and 52 other locations)
Trial IDNCT06551142 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety, tolerability, clinical activity, and pharmacokinetics of GSK5764227 in participants with advanced solid tumors. It will assess how the drug's levels change over time at various doses, both alone and in combination with other cancer treatments such as carboplatin, cisplatin, and immunotherapies. Participants will be closely monitored for their response to the treatment and any side effects experienced during the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors who have progressed on standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies involving similar drug combinations have shown promise, but the specific approach of GSK5764227 is novel.

Eligibility criteria

Show full inclusion / exclusion 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:

  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)
* Additional inclusion criteria for Phase 1b Chinese participants:

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
* All participants who do not meet either of the above-mentioned inclusion criteria for Chinese participants will be considered as global (non-Chinese) participants.

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:

  * 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.

Additional exclusion criteria for participants receiving combination therapy

* 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.

Where this trial is running

Stanford, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NeoplasmsSolid TumorsGSK5764227EMBOLD PanTumor-101
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.