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TSR-011

Phase 1

Solid Tumors | Small molecule | Oncology |GSK plc|Last Updated: Mar 26, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

TSR-011 · 1 trial · 2 indications

Phase 1 1
NCT02048488A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and LymphomasSolid Tumors
COMPLETED72 Analytics
PHASE1COMPLETED
A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas
Solid Tumors
NCT0204848872
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Study Endpoints

Primary Endpoints

Incidence of Adverse Events (AEs)
Approximately 2 years

Secondary Endpoints

Area Under the Concentration-Time Curve (AUC)
Day 1: 0-24 hrs after first dose; pre-dose on days 8 & 15; day 29: 0-24 hours
Maximum Tolerated Dose (MTD)
28 days after first dose
Response Rate (RR)
approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental Drug TSR-011EXPERIMENTALExperimental Drug TSR-011

Interventions

NameTypeDescription
TSR-011DRUGNumber of cycles until progression or unacceptable toxicity develops.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * To be considered eligible to participate in this study, all of the following requirements must be met: 1. Patients in Phase 1 must have metastatic or locally advanced solid tumors who have failed to respond to standard therapy 2. All patients must have confirmation of eit...

Countries:United StatesPolandSpainTaiwanUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about TSR-011

What is TSR-011 used for?

TSR-011 is an investigational small molecule being studied for the treatment of solid tumors and lymphomas. It is an oral therapy evaluated in patients with advanced solid tumors and lymphomas. The drug is in Phase 1 clinical development and is not yet approved for any use.

Who makes TSR-011?

TSR-011 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The drug is an investigational oncology small molecule currently in Phase 1 clinical development for solid tumors and lymphomas.

What phase is TSR-011 in?

TSR-011 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of advanced solid tumors and lymphomas, and its Phase 1 trial has been completed.

What clinical trials is TSR-011 in?

TSR-011 has one completed clinical trial, identified as NCT02048488. This was a Phase I/IIa open-label, dose escalation and cohort expansion trial of oral TSR-011 in patients with advanced solid tumors and lymphomas. The trial enrolled 72 participants across the United States, Poland, Spain, Taiwan, and the United Kingdom.

Is TSR-011 the same as any other drug?

No alternative names for TSR-011 have been disclosed. The drug is referred to solely as TSR-011 in its clinical trial documentation. It is an investigational small molecule being developed by GSK plc for the treatment of solid tumors and lymphomas.