A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • GSK5926371

    Drug

    GSK5926371 will be administered at different dose levels.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: GSK5926371Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with dose limiting toxicities (DLTs)

Time frame
Up to 28 days
2

Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity

Time frame
Up to approximately 169 weeks

Secondary outcomes

1

Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)

Time frame
Up to approximately 169 weeks
2

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.

Time frame
Up to approximately 169 weeks
3

Maximum concentration (Cmax) of GSK5926371

Time frame
Up to approximately 169 weeks
4

Time to Cmax (Tmax) of GSK5926371

Time frame
Up to approximately 169 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: