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XMT-1107

Phase 1

Neoplasm Metastasis | Small molecule | Oncology |Day One Biopharmaceuticals, Inc.|Last Updated: Jan 31, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01011972A Study of Intravenous XMT-1107 in Patients With Advanced Solid TumorsPHASE1 COMPLETED 52Mar 1, 2010Sep 1, 2013Jan 31, 20184 United States
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Study Endpoints
Primary Endpoints
The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 when given via IV once every three weeks.
Adverse events are assessed during each treatment cycle.
Secondary Endpoints
Assess the pharmacokinetics (PK) of XMT-1107 and its release product
Samples for PK are collected during Cycle 1 and prior to each subsequent treatment cycle
Determine the recommended Phase 2 dose of XMT-1107
Throughout Cycle 1
Assess the safety of XMT-1107.
Throughout Cycle 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XMT-1107EXPERIMENTALDose escalation groups of XMT-1107, I.V. (in the arm) beginning at 6 mg/m\^2, doubling in dose to 24 mg/m\^2, then 40 mg/m\^2, then 60 mg/m\^2, then 80 mg/m\^2 with subsequent doses at 33% of the previous until disease progression or unacceptable side effects are experienced.
Interventions
NameTypeDescription
XMT-1107DRUG6 mg XMT-1107 administered by I.V. (in the vein) administered over 90 min, once every 21 days : until progression or unacceptable toxicity develops
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patient must have a histological diagnosis of advanced solid tumor and must be refractory to standard therapy or have no effective therapy. * Measurable or evaluable disease. * At least 42 days since administration of mitomycin or nitrosoureas and 28 days since any other chemo...

Countries:United States
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