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About
This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of GSK4381562 in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.
Enrollment
Sex
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Volunteers
Inclusion criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows:
Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists.
•Measurable disease per RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Life expectancy of at least 12 weeks.
Adequate organ function, as defined in the protocol.
For participants enrolled in a PK/PD cohort, participant agrees to a fresh tumor biopsy during Screening and at approximately 6-weeks after treatment initiation.
Exclusion criteria
Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of GSK4381562):
Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
Toxicity from previous anticancer treatment, including:
Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.
Primary purpose
Allocation
Interventional model
Masking
162 participants in 4 patient groups
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Central trial contact
EU GSK Clinical Trials Call Center; US GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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