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I124-NM404

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |Cellectar Biosciences, Inc.|Last Updated: May 22, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

I124-NM404 · 1 trial · 1 indication

Phase 1 1
NCT00582283NM404 as an Imaging Agent in Patients With NSCLCNon Small Cell Lung Cancer
COMPLETED21 Analytics
PHASE1COMPLETED
NM404 as an Imaging Agent in Patients With NSCLC
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
5 days

The objective of this protocol is to obtain preliminary data on imaging NSCLC tumors. Images with 124I-NM404 will be evaluated by a nuclear medicine consultant, who will be blind to the participants' clinical findings and other radiographic images. The nuclear medicine consultant will independently record his findings, and then compare his results with those obtained by conventional FDG-PET imaging that was done at baseline as part of this study. This comparison will be only qualitative.

Secondary Endpoints

Semi-quantitative lesion scoring to evaluate Tumor biodistribution
up to 7 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Diagnostic: iodine I-124 NM404 CT/PET scanOTHERPatients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.

Interventions

NameTypeDescription
I124-NM404DRUGI-124-NM404
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Part 3 * Histologically or cytologically documented NSCLC with measurable of disease * Disease is evaluable by CT scan * At least 18 years old. Women cannot be pregnant or breastfeeding * Karnofsky score \>/= to 60 * Adequate renal/hepatic function * Adequate blood cell count le...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about I124-NM404

What is I124-NM404 used for in Non Small Cell Lung Cancer?

I124-NM404 is an investigational small molecule being studied for use in Non Small Cell Lung Cancer (NSCLC). It was evaluated in a Phase 1 clinical trial as an imaging agent in patients with NSCLC. The drug is being developed by Cellectar Biosciences, Inc. (CLRB) and is currently in clinical development.

What does I124-NM404 target?

The molecular target of I124-NM404 has not been disclosed. It is a small molecule being studied as an imaging agent in Non Small Cell Lung Cancer. The drug is in Phase 1 clinical development by Cellectar Biosciences, Inc. (CLRB).

Who makes I124-NM404?

I124-NM404 is being developed by Cellectar Biosciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CLRB. The company is conducting clinical research on this investigational small molecule for Non Small Cell Lung Cancer.

What phase is I124-NM404 in?

I124-NM404 is in Phase 1 clinical development. It has completed one Phase 1 trial in Non Small Cell Lung Cancer. The drug is investigational and has not been approved by the FDA. Cellectar Biosciences, Inc. (CLRB) is the developer.

What clinical trials is I124-NM404 in?

I124-NM404 has been studied in one completed Phase 1 clinical trial, identified as NCT00582283. This trial evaluated NM404 as an imaging agent in patients with Non Small Cell Lung Cancer in the United States. The study enrolled 21 participants and was not randomized or blinded.

Is I124-NM404 the same as NM404?

Yes, I124-NM404 is also known as NM404. The completed Phase 1 clinical trial NCT00582283 used the name NM404 in its title. Both names refer to the same investigational small molecule being developed by Cellectar Biosciences, Inc. (CLRB) for Non Small Cell Lung Cancer.