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New treatment option for Neoplasms
Official title A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
ClinicalTrials.gov ID: NCT06551142
What this study is testing
What is Ris-Rez?
Ris-Rez is an investigational medicine, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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:
- 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Fort Wayne, Indiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New Brunswick, New Jersey, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Tyler, Texas, United States
- West Valley City, Utah, United States
- Norfolk, Virginia, United States
- Rosario, Argentina
- Viedma, Argentina
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Fort Wayne, Indiana, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.