Clareo Health | A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
IDEAYA Biosciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 GSK4418959 (alone or in combination with PD-1 inhibitor, as determined between Investigator and sponsor) as next line of 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
Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options
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
You may not be if
Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced AEs
Has received prior treatment with a WRN inhibitor
Is unable to swallow and retain orally administered study treatment
Has symptomatic uncontrolled brain or leptomeningeal metastases
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 cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer that is considered to be low risk for progression by the investigator
Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs
Has severe liver fibrosis
Has cirrhosis or current unstable liver or biliary disease
Has known hypersensitivity to any of the study interventions or any of their excipients
Has known WRN syndrome
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has experienced any of the following with prior immunotherapy: any immune mediated adverse events (imAE) of Grade ≥3, immune-related severe neurologic events of any grade, exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug rash with eosinophilia and systemic signs syndrome \[DRESS\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary
Has any history of interstitial lung disease or pneumonitis
