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PNT2258

Phase 2

Lymphoma, Diffuse Large B-Cell | Small molecule | Oncology |GSK plc|Trials Updated: Jun 29, 2023

PNT2258 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Aug 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials3
Total Enrollment80

FDA Designations

No designations recorded

PNT2258 clinical trials

PNT2258 · 3 trials · 6 indications

Phase 2 2Phase 1 1
NCT02226965PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)Lymphoma, Diffuse Large B-Cell
COMPLETED45 Analytics
NCT01733238Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's LymphomaLymphoma, Non-Hodgkin's
COMPLETED13 Analytics
PHASE2COMPLETED
PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)
Lymphoma, Diffuse Large B-CellUnlock trial analytics
PHASE2COMPLETED
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Lymphoma, Non-Hodgkin'sUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate
19 months

The proportion of patients with complete response (CR/complete metabolic response \[CMR\]) or partial response (PR/partial metabolic response \[PMR\]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)

To determine the safety of PNT2258 in patients with advanced solid tumors
Ongoing

Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose

Secondary Endpoints

Disease Control Rate
19 months
Time to Response
19 months
Progression-free Survival
19 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PNT2258EXPERIMENTALPNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.

Interventions

NameTypeDescription
PNT2258DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy or relapsed after prior therapy. FDG PET-CT (disease) positive baseline scan with measurable disease. The patient must have received prior therapy that included: * CD20-targeted therapy...

Countries:United StatesPuerto Rico
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Frequently asked questions about PNT2258

What is PNT2258 used for?

PNT2258 is an investigational small molecule being studied for the treatment of cancer, including lymphoma, diffuse large B-cell lymphoma, and non-Hodgkin's lymphoma. It has been evaluated in clinical trials for advanced solid tumors and relapsed or refractory lymphomas.

Who is developing PNT2258?

PNT2258 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK.

What phase is PNT2258 in?

PNT2258 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. Its development status is based on completed trials in oncology indications.

What clinical trials has PNT2258 been in?

PNT2258 has been studied in three completed clinical trials: NCT01191775 in advanced solid tumors, NCT01733238 in relapsed or refractory non-Hodgkin's lymphoma, and NCT02226965 in relapsed or refractory diffuse large B-cell lymphoma. These trials were conducted in the United States and Puerto Rico.

Is PNT2258 the same as any other drug?

PNT2258 is a distinct investigational small molecule. No alternative names for PNT2258 have been reported in the clinical trial information available.