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ZIO-201

Phase 1

Advanced Cancer | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Jan 31, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

ZIO-201 · 2 trials · 2 indications

Phase 1 2
NCT00421135A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced CancerAdvanced Cancer
COMPLETED30 Analytics
NCT00439686Study of ZIO-201 in Advanced SarcomaAdvanced Sarcoma
COMPLETED53 Analytics
PHASE1COMPLETED
A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer
Advanced CancerUnlock trial analytics
PHASE1COMPLETED
Study of ZIO-201 in Advanced Sarcoma
Advanced SarcomaUnlock trial analytics

Study Endpoints

Primary Endpoints

toxicities
6 months

Secondary Endpoints

pharmacokinetics
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTALZIO-201

Interventions

NameTypeDescription
ZIO-201DRUGZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Metastatic and /or unresectable disease state after previous standard chemotherapy

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about ZIO-201

What is ZIO-201 used for?

ZIO-201 is an investigational small molecule being studied for the treatment of advanced sarcoma and advanced cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who is developing ZIO-201?

ZIO-201 is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TCRT.

What phase is ZIO-201 in?

ZIO-201 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use.

What clinical trials has ZIO-201 been in?

ZIO-201 has been studied in two completed Phase 1 clinical trials. One trial (NCT00421135) evaluated the safety and tolerance of intravenous ZIO-201 in patients with advanced cancer, enrolling 30 participants. Another trial (NCT00439686) studied ZIO-201 in advanced sarcoma, enrolling 53 participants.

Is ZIO-201 the same as isophosphoramide mustard?

ZIO-201 is also known as isophosphoramide mustard (IPM). In clinical trials, it has been referred to as intravenous IPM, indicating that ZIO-201 and IPM are the same compound.