GSK5764227 given with standard therapies for advanced solid tumors
A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors
This trial will test whether GSK5764227, a drug that delivers a toxin directly to cancer cells, can be safely given alongside standard treatments in adults with advanced solid tumors such as metastatic colorectal cancer or metastatic castration-resistant prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 6 sites (Lake Success, New York and 5 other locations) |
| Trial ID | NCT07277270 on ClinicalTrials.gov |
What this trial studies
This is an early-phase (Phase 1) trial testing GSK5764227 in combination with standard-of-care agents like bevacizumab, fluorouracil/leucovorin, or enzalutamide in participants with advanced solid tumors. The study will use dose-escalation and expansion cohorts to define safety, tolerability, and how the body processes the drug (pharmacokinetics). Researchers will also monitor for immune responses to the drug and look for signs that tumors shrink or stop growing. Participants will be closely followed for side effects and treatment-related complications.
Who should consider this trial
Good fit: Adults with unresectable or metastatic colorectal adenocarcinoma (cohort A) or adenocarcinoma of the prostate (cohort B) with ECOG performance status 0–1 and adequate organ function who meet other enrollment criteria are the intended participants.
Not a fit: Patients with recent major surgery, untreated brain/CNS metastases, serious infection, clinically significant bleeding tendencies, or another progressing malignancy within the past 24 months are unlikely to be eligible and may not benefit from participation.
Why it matters
Potential benefit: If successful, the drug could better target and kill tumor cells while limiting damage to healthy tissue, potentially shrinking tumors or controlling disease.
How similar studies have performed: Antibody–drug conjugates that deliver toxins to cancer cells have shown meaningful benefit in several cancer types, but combining new ADCs with standard agents is still experimental and results have varied by tumor type and drug.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose. * Has adequate organ function. * Has histologically confirmed unresectable adenocarcinoma or unresectable metastatic adenocarcinoma of the colon or rectum. (Cohort A) * Histologically or cytologically confirmed adenocarcinoma of the prostate (Cohort B) Exclusion Criteria: * Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of disease. * Has had any major surgery within 28 days prior to first dose. * Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. * Has serious infection within 4 weeks prior to the first dose, * Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed * Any evidence of current interstitial lung disease (ILD) or pneumonitis OR a prior history of ILD requiring high-dose glucocorticoids or non-infectious pneumonitis requiring high-dose glucocorticoids. * Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. * Has received immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term \[30 days or longer\]). Low-dose corticosteroids (prednisone ≤10 milligrams (mg)/day or equivalent) may be administered.
Where this trial is running
Lake Success, New York and 5 other locations
- GSK Investigational Site — Lake Success, New York, United States (Recruiting)
- GSK Investigational Site — Tugun, Queensland, Australia (Recruiting)
- GSK Investigational Site — Barcelona, Spain (Recruiting)
- GSK Investigational Site — Madrid, Spain (Recruiting)
- GSK Investigational Site — Madrid, Spain (Recruiting)
- GSK Investigational Site — Málaga, Spain (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.