Testing GSK5764227 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• GSK Investigational Site
  Stanford, California, United States Recruiting
• GSK Investigational Site
  Denver, Colorado, United States Recruiting
• GSK Investigational Site
  New Haven, Connecticut, United States Recruiting
• GSK Investigational Site
  Fort Wayne, Indiana, United States Recruiting
• GSK Investigational Site
  Boston, Massachusetts, United States Recruiting
• GSK Investigational Site
  Detroit, Michigan, United States Recruiting

+17 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HR20013 for preventing nausea and vomiting in cancer patients receiving chemotherapy

  This real-world study tests whether HR20013 helps prevent nausea and vomiting in adults with cancer who are getting chemotherapy.

  Recruiting Sun Yat-sen University · Guangzhou, Guangdong · NCT07874308

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

• Ready for Safe Cancer Treatment (RESET): A comprehensive perioperative program for surgical patients

  The RESET program tests a structured, multidisciplinary perioperative plan to improve safety and recovery for adults having planned cancer surgery and older adults having planned non cancer-related surgery.

  Recruiting at 2 sites Regional Specialist Hospital in Wroclaw · Wroclaw, Lower Silesian Voivodeship and 1 other locations · NCT07727876

• How environment and biology together predict health, aging, and death

  Researchers are following adults to see how living conditions and biology together relate to aging and life expectancy, by linking personal health data with environmental and social information over time.

  Recruiting Longevity Metrics, Inc. · Boulder, Colorado · NCT07646782

• Metastatic liver cancer patient registry from multiple Chinese centers

  This is a registry that collects real-world data on adults with liver metastases to understand patterns and prognosis and to support future research.

  Recruiting at 2 sites Anhui Provincial Hospital · Bengbu, Anhui and 2 other locations · NCT07602504

• TriAdeno and N-803 vaccine in early prostate cancer on active surveillance

  A vaccine combo called TriAdeno plus the N-803 drug is being tested to see if it can help slow or stop growth in men with early-stage, low- to intermediate-risk prostate cancer who are being watched rather than treated right away.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07574541

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.