About this trial
The goal of this clinical trial is to learn if drug GSK5926371 works to treat a form of B-cell cancer (a type of blood cancer) that has returned or failed to respond to prior therapies in adults. The study will primarily assess the drugs safety and tolerability in participants. Additionally, it seeks to determine the clinical efficacy and pharmacokinetic (PK) properties of GSK5926371.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,
Has measurable disease,
Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication;
Willing to use adequate contraception (Participant of childbearing potential [POCBP] only).
Disqualifiers
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 metastatic disease.
Has had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications.
Has a history of Progressive multifocal leukoencephalopathy (PML), current central nervous system (CNS) involvement by lymphoma, or a history of significant CNS disease such as uncontrolled seizures, stroke, epilepsy, CNS vasculitis, and neurodegenerative conditions.
Has an active uncontrolled infection.
Trial design
Sequential
Treatments tested in this trial
GSK5926371
DrugGSK5926371 will be administered at different dose levels.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with dose limiting toxicities (DLTs)
Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity
Secondary outcomes
Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants in the ORR evaluable set with the best overall response of confirmed partial response (PR) or better per Lugano guidelines as assessed by investigator.
Maximum concentration (Cmax) of GSK5926371
Time to Cmax (Tmax) of GSK5926371
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: