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RecruitingPhase 1 / Phase 2

A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

A Phase 1/2 Open-label, Multicenter Study of Oral GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) 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 GSK5460025 in people with advanced solid tumors, which are lumps of cancer tissue, with certain gene-related features. It will check whether the drug shrinks tumors, what side effects it causes, and how the body processes it. Other cancer drugs may be added in future study updates.

Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti-cancer agents can decrease tumor size, is safe, well-tolerated, and how the drug is processed in the body over time.

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

Eligibility

Who can join

  • Have a solid tumor confirmed by a tissue test that cannot be removed by surgery, has spread, or has come back. For Part 1, all standard treatment options must have been used.
  • Have known dMMR/MSI-H tumor features, which involve problems with DNA repair, or have an unknown status that the study lab will test.
  • Provide a stored or new tumor tissue sample and plan to receive GSK5460025 as your next treatment.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours. Be expected to live at least 3 months.
  • Have organs that work well enough to meet the study's rules.
  • For Part 2, have advanced cancer of the colon or rectum, or of the lining of the uterus.
  • For Part 2, have received 1 to 3 courses of drug treatment for advanced cancer, including at least one immune checkpoint inhibitor, a drug that helps the immune system fight cancer.
  • For Part 2, have at least one tumor that the study doctor can measure during screening.

Who can't join

  • Side effects from earlier cancer treatment have not returned to your usual level or become mild.
  • Have received a WRN inhibitor or NERT agent, types of drugs that target DNA repair.
  • Cannot swallow or keep down the study drug.
  • Have cancer that has spread to the brain or central nervous system and is untreated or has worsened.
  • Have another cancer that worsened or needed active treatment in the past 2 years. Some skin cancers and cancers that stayed where they started are allowed if removed and not spread.
  • Have stomach or bowel problems that could greatly affect how your body absorbs the drug.
  • Have liver scarring called cirrhosis, or current unstable disease of the liver or bile system.
  • Have a known allergy to a study treatment or any of its ingredients.

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

Official eligibility criteria

Inclusion Criteria: * Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor * Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory * Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample * Intends to receive GSK5460025 as next treatment * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Is expected to have a minimum of 3 months life expectancy * Has adequate organ function, as defined in the protocol Part 1 inclusion criteria: • Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options Part 2 inclusion criteria: * Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC) * Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy * Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator Exclusion Criteria: * Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs) * Has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent. * Is unable to swallow and retain orally administered study treatment * Has untreated or progressed metastases in brain or CNS * Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease. * Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs * Has cirrhosis or current unstable liver or biliary disease * Has known hypersensitivity to any of the study interventions or any of their excipients

Study sites (4)

CO

MI

OH

TN