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eFT508

Phase 2

Microsatellite Stable Relapsed or Refractory Colorectal Cancer | Small molecule | Oncology |Merck KGaA|Trials Updated: Jul 18, 2019

eFT508 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Aug 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

eFT508 clinical trials

eFT508 · 1 trial · 1 indication

Phase 2 1
NCT03258398A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal CancerMicrosatellite Stable Relapsed or Refractory Colorectal Cancer
COMPLETED56 Analytics
PHASE2COMPLETED
A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer
Microsatellite Stable Relapsed or Refractory Colorectal Cancer
NCT0325839856
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Study Endpoints

Primary Endpoints

Part 1: Proportion of subjects with a dose limiting toxicity (DLT) during the first treatment cycle
28 days
Part 2: Overall Response Rate
8-16 weeks

the proportion of subjects whose best overall response is a complete or partial response

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: eFT508 plus avelumab dose finding ArmEXPERIMENTALsubjects will receive eFT508 in combination with a fixed dose of avelumab
Part 2: eFT508 plus avelumabEXPERIMENTALsubjects will receive eFT508 in combination with a fixed dose of avelumab
Part 2: eFT508 aloneEXPERIMENTALsubjects will receive eFT508 alone

Interventions

NameTypeDescription
eFT508DRUGeFT508 will be taken orally (PO) twice a day (bid).
AvelumabDRUGAvelumab 10 mg/kg will be administered intravenously (IV) on Day 1 and once every 2 weeks (q2wk) thereafter
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * ECOG performance status of 0, 1, or 2 * Pathologically documented diagnosis of colorectal adenocarcinoma. * Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease. * Completion of all previous therapy (including surgery, rad...

Countries:United States
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