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A Study of Ris-Rez for Advanced Solid Tumors (EMBOLD)

This study is looking at a new medicine called Ris-Rez (also known as GSK5764227) for people with advanced solid tumors (cancers that form solid masses). The main goals are to understand if Ris-Rez is safe, how well your body handles it, and how it works, both on its own and when given with other common cancer medicines like Cisplatin, Carboplatin, Atezolizumab, and Pembrolizumab. We'll also see how the levels of Ris-Rez change in your body over time. To join, you must be at least 18 years old and have advanced solid tumors. The study will measure side effects and how well the treatment is tolerated.

Study design
This is an interventional study with a planned enrollment of 845 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to approximately 28 to 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06551142

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
GlaxoSmithKline
~845 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Ris-RezCisplatinCarboplatinAtezolizumabPembrolizumabDurvalumab

At a glance

Recruiting sites
66 of 67 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of participants with Adverse Events (AEs)
Measured over Up to approximately 28 months
+5 more outcomes measured

Conditions

Neoplasms

Explore related trials

Solid Neoplasm

NCT06551142

Where you'd take part

This study runs at 67 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • GSK Investigational Site

    Stanford, Californiastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Denver, Coloradostudy coordinator listed

    Recruiting

  • GSK Investigational Site

    New Haven, Connecticutstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Fort Wayne, Indianastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    New Brunswick, New Jerseystudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Myrtle Beach, South Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Eligibility criteria

Inclusion

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:
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

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 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.

What this trial measures

  • Phase 1a: Number of participants with Adverse Events (AEs)Up to approximately 28 months
  • Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)Up to 21 days
  • Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severityUp to approximately 30 months
  • Phase 1a: Number of participants with AEs leading to dose modificationsUp to approximately 28 months
  • Phase 1a: Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance statusUp to approximately 28 months
  • Phase 1b: Confirmed Objective Response Rate (cORR)Up to approximately 27 months

    cORR is defined as the proportion of participants who have confirmed Complete response (CR) or Partial response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) criteria or other imaging criteria for defined tumor types.