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ZIO-101

Phase 1

Solid Tumors | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Jul 19, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

ZIO-101 · 3 trials · 7 indications

Phase 1 3
NCT00303199Study of ZIO-101 in Multiple MyelomaMultiple Myeloma
COMPLETED35 Analytics
NCT00591396A Phase I Trial of ZIO-101 in Solid TumorsSolid Tumors
COMPLETED40 Analytics
NCT00592046A Phase I Trial of ZIO-101 in Hematologic CancersAcute Leukemia
COMPLETED12 Analytics
PHASE1COMPLETED
Study of ZIO-101 in Multiple Myeloma
Multiple MyelomaUnlock trial analytics
PHASE1COMPLETED
A Phase I Trial of ZIO-101 in Solid Tumors
Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Phase I Trial of ZIO-101 in Hematologic Cancers
Acute LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03
6 months
Phase II efficacy using EMBT criteria.
6 months
Safety
6 months
toxicities
6 months
Response Rate
6 months

Secondary Endpoints

Pharmacokinetics of ZIO-101
6 months
pharmacokinetics
6 months
The RECIST criteria will be used for patients with all leukemias and myelodysplastic syndromes.
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
ZIO-101 (Darinaparsin)DRUGIV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

Countries:United StatesCanada
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about ZIO-101

What is ZIO-101 used for?

ZIO-101 is an investigational small molecule being studied for the treatment of acute leukemia, multiple myeloma, and solid tumors. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being developed by Alaunos Therapeutics, Inc. (NASDAQ: TCRT).

What does ZIO-101 target?

ZIO-101 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its potential anti-cancer activity in hematologic malignancies and solid tumors, though the exact mechanism of action is not publicly detailed.

Who makes ZIO-101?

ZIO-101 is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TCRT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various cancers.

What phase is ZIO-101 in?

ZIO-101 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. All three clinical trials for ZIO-101 have been completed, and the drug is no longer in active testing.

What clinical trials is ZIO-101 in?

ZIO-101 has completed three Phase 1 trials: NCT00303199 in multiple myeloma (35 patients), NCT00591396 in solid tumors (40 patients), and NCT00592046 in hematologic cancers including acute leukemia and multiple myeloma (12 patients). All trials are completed and were uncontrolled, non-randomized studies.

Is ZIO-101 the same as other drugs?

ZIO-101 is the primary name for this investigational compound. No alternative names have been reported in clinical trial registrations. It is a distinct small molecule being developed by Alaunos Therapeutics for oncology indications.