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RecruitingPhase 1

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests GSK5764227 with standard treatments or other medicines in people with advanced solid tumors, including colon, rectal, or prostate cancer. GSK5764227 is designed to carry a toxin to cancer cells to kill them while sparing healthy cells. Researchers will check its safety, how the body handles it, whether the immune system reacts to it, and whether it shrinks or controls cancer.

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can do normal daily activities, though hard physical activity may be limited. This has not worsened in the 2 weeks before your first dose.
  • Your organs work well enough for the study.
  • For group A: A tissue test confirms adenocarcinoma, a cancer that starts in gland cells, in the colon or rectum. It cannot be removed by surgery and may have spread.
  • For group B: A tissue or cell test confirms adenocarcinoma, a cancer that starts in gland cells, in the prostate.

Who can't join

  • You had another cancer that grew or needed treatment in the past 24 months. Exceptions include certain skin cancers or cancers that stayed where they started, if removed with no signs of cancer left.
  • You had major surgery within 28 days before your first dose.
  • You had serious bleeding symptoms or a strong tendency to bleed within 1 month before your first dose.
  • You had a serious infection within 4 weeks before your first dose.
  • Cancer has spread to your brain or central nervous system and has not been treated or has worsened.
  • You have lung inflammation or scarring called interstitial lung disease, or lung inflammation called pneumonitis. You also cannot join if you previously needed high-dose steroids for interstitial lung disease or pneumonitis not caused by infection.
  • You have an autoimmune disease, where the immune system attacks your body, that needed treatment affecting the whole body in the 2 years before screening.
  • You took medicines that weaken the immune system within 30 days before your first dose, or need them for 30 days or longer. Low-dose steroids are allowed: prednisone at 10 mg a day or less, or a matching dose of another steroid.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (5)

FL

NY

PA

TN

TX