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ZIO-201-T and doxorubicin

Phase 1

Advanced Cancer | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Sep 17, 2009

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00608803Phase 1 Study of ZIO-201-T in Combination With Doxorubicin in Solid TumorsPHASE1 COMPLETED 30Jan 1, 2008Jan 1, 2009Sep 17, 20092 United States
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Study Endpoints
Primary Endpoints
Toxicities
5 months
Secondary Endpoints
Pharmacokinetics
5 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single armEXPERIMENTALOnce the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy.
Interventions
NameTypeDescription
ZIO-201-T and doxorubicinDRUGZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age ≥18 years * Histological or cytological documentation of cancer * Measurable disease * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Ifosfamide and doxorubicin naïve * Life expectancy of at least 12 weeks * Adequate bone marrow, liver, and re...

Countries:United States
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