Recent Updates
Recently added Catalysts

TSR-011

Phase 1

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

TSR-011 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2014

TSR-011 target and mechanism

ModalitySmall molecule

Also known as TRK inhibitor

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

TSR-011 clinical trials

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 TumorsUnlock trial analytics

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about TSR-011

What is TSR-011 used for?

TSR-011 is an investigational small molecule being studied in adults with advanced solid tumors and lymphomas. It was evaluated in a Phase 1/2a dose escalation and cohort expansion trial in patients with these advanced cancers. It is not an approved therapy and remains in clinical development.

Who is developing TSR-011?

TSR-011 is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK holds the development program for this oral small molecule oncology candidate.

What phase is TSR-011 in?

TSR-011 is in Phase 1 development. The single registered trial, NCT02048488, was a Phase 1/2a study that has been completed, and no trials are currently listed as active. The program remains investigational and has not been approved for any indication.

What clinical trials is TSR-011 in?

TSR-011 was studied in one trial, NCT02048488, titled a Phase I/IIa open-label dose escalation and cohort expansion trial of oral TSR-011 in patients with advanced solid tumors and lymphomas. It enrolled 72 patients across the United States, Poland, Spain, Taiwan, and the United Kingdom, and is completed.

How was the TSR-011 trial designed?

NCT02048488 was an open-label, uncontrolled Phase 1/2a dose escalation and cohort expansion study of oral TSR-011 in patients aged 18 years and older with advanced solid tumors and lymphomas. It was not randomized and not blinded, and it enrolled 72 participants, including biomarker-selected patients.