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IMMU-130

Phase 1

Metastatic Colorectal Cancer | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 19, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

IMMU-130 · 1 trial · 1 indication

Phase 1 1
NCT01270698Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal CancerMetastatic Colorectal Cancer
COMPLETED26 Analytics
PHASE1COMPLETED
Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years

The primary outcome measured will be safety of IMMU-130 administered at different dose levels. Safety will be assessed by reviewing the number of adverse events and overall toxicity.

Secondary Endpoints

efficacy
Efficacy will be measured every 8-12 weeks during treatment and every 6 months during the 2nd year and then annually up to 5 years thereafter.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMMU-130EXPERIMENTAL -

Interventions

NameTypeDescription
IMMU-130DRUGIMMU-130 will be administered intravenously every 2 weeks for up to 6 months or longer.
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Eligibility Criteria

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

Inclusion Criteria: * Male or female patients, \>18 years of age, able to understand and give written informed consent. * Histologically or cytologically confirmed colorectal adenocarcinoma. * Stage IV (metastatic) disease. * Failed at least one prior standard treatment regimen for colorectal cance...

Countries:United States
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Metastatic Colorectal Cancer")

Frequently asked questions about IMMU-130

What is IMMU-130 used for?

IMMU-130 is an investigational small molecule being studied for the treatment of metastatic colorectal cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. A completed Phase 1 trial evaluated its use in patients with relapsed or refractory colorectal cancer.

Who makes IMMU-130?

IMMU-130 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with metastatic colorectal cancer.

What phase is IMMU-130 in?

IMMU-130 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. One Phase 1 trial has been completed, which enrolled 26 patients with metastatic colorectal cancer in the United States.

What clinical trials is IMMU-130 in?

IMMU-130 has one completed clinical trial, identified as NCT01270698, titled 'Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal Cancer.' This Phase 1 trial enrolled 26 patients with metastatic colorectal cancer in the United States and has been completed.

Is IMMU-130 FDA approved?

No, IMMU-130 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for metastatic colorectal cancer. The drug has completed one Phase 1 trial, but it remains under investigation and has not been approved for any use.