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INXN-1001

Phase 2

Melanoma | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Trials Updated: Jul 18, 2013

INXN-1001 development status

Highest phase Phase 2 (NCT04006119)
Phase scored for TCRTPhase 1
Registered trials 8 across 2 sponsors since Dec 2008

INXN-1001 target and mechanism

Molecular targetmIL-12
Target classCytokine
ModalitySmall molecule

Also known as veledimex, Activator Ligand

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

INXN-1001 clinical trials

INXN-1001 · 1 trial · 1 indication

Phase 1 1
NCT00815607Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV MelanomaMelanoma
COMPLETED12 Analytics
PHASE1COMPLETED
Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scans
throughout the study

Secondary Endpoints

PK of oral Activator Ligand, Immunologic responses, particularly frequency of CTLs and Tregs and hIL-12 and other cytokine levels in injected target tumor(s) and in peripheral blood, Efficacy.
throughout the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
INXN-1001DRUGCapsules given once daily for 14 days for 3 treatment cycles.
INXN-3001BIOLOGICALIntratumoral injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Males or females of all races ≥ 18 years of age and ≤ 75 years of age; 2. Unresectable Stage III C (in transit) or Stage IV melanoma (M1a, M1b, M1c with LDH ≤ 2x ULN), arising from primary cutaneous, mucosal, or subungual melanoma of any tumor thickness or from an unknown pri...

Countries:United States
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Frequently asked questions about INXN-1001

What is INXN-1001 used for?

INXN-1001 is an investigational small molecule developed for the treatment of melanoma, including advanced disease. It has been studied in a Phase 1 trial in subjects with Stage III or IV melanoma. It is not an approved therapy and remains in clinical development.

What does INXN-1001 target?

INXN-1001 targets mIL-12, a cytokine. By acting on this molecular target, the drug is designed to influence cytokine-mediated immune activity in the tumor setting. This mechanism underlies its evaluation as an intratumoral approach in melanoma.

Who is developing INXN-1001?

INXN-1001 is being developed by Alaunos Therapeutics, Inc., which trades under the ticker TCRT. The company is the sponsor of the clinical program evaluating the agent in melanoma.

What phase is INXN-1001 in?

INXN-1001 is in Phase 1 development. The program includes one completed Phase 1 trial, and no active trials are ongoing. The drug is investigational and has not been approved for any indication.

What clinical trials is INXN-1001 in?

INXN-1001 has been evaluated in the completed Phase 1 trial NCT00815607, titled Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV Melanoma. The trial enrolled 12 participants in the United States and studied patients with melanoma.