Recent Updates
Recently added Catalysts

INXN-1001

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about INXN-1001

What is INXN-1001 used for in melanoma?

INXN-1001 is an investigational small molecule being studied for the treatment of melanoma. It is administered via intratumoral injections and is currently in Phase 1 clinical development. The drug is not yet approved and remains under investigation for this indication.

Who makes INXN-1001?

INXN-1001 is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company. The company is publicly traded on the NASDAQ under the ticker symbol TCRT. The drug is in Phase 1 clinical development for melanoma.

What phase is INXN-1001 in?

INXN-1001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial of the drug has been completed, and it remains under investigation for the treatment of melanoma.

What clinical trials is INXN-1001 in?

INXN-1001 has been studied in one clinical trial, identified as NCT00815607. This was a Phase 1, uncontrolled, open-label trial of intratumoral injections of INXN-3001 in subjects with Stage III or IV melanoma. The trial was completed in the United States and enrolled 12 participants.

Is INXN-1001 the same as INXN-3001?

INXN-1001 is not the same as INXN-3001. The completed clinical trial NCT00815607 evaluated intratumoral injections of INXN-3001, a different drug candidate. INXN-1001 is a separate investigational small molecule being developed by Alaunos Therapeutics for melanoma.