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IMMU-107

Phase 3

Pancreatic Cancer | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Trials Updated: Aug 19, 2021

IMMU-107 development status

Highest phase Phase 3 (NCT01956812)
Phase scored for GILDPhase 1
Registered trials 4 across 1 sponsor since Jan 2008

IMMU-107 target and mechanism

ModalityMonoclonal antibody

Also known as IMMU-107 (hPAM4), hPAM4, 90Y-hPAM4, anti-mucin antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment101

FDA Designations

No designations recorded

IMMU-107 clinical trials

IMMU-107 · 2 trials · 1 indication

Phase 1 2
NCT00603863Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic CancerPancreatic Cancer
COMPLETED80 Analytics
NCT00597129Safety and Efficacy Study of 90Y-hPAM4 at Different DosesPancreatic Cancer
COMPLETED21 Analytics
PHASE1COMPLETED
Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer
Pancreatic CancerUnlock trial analytics
PHASE1COMPLETED
Safety and Efficacy Study of 90Y-hPAM4 at Different Doses
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
over 12 weeks
safety MTD
over the first 12 weeks, then over 2 years

Secondary Endpoints

Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc.
over 5 years
targeting, biodistribution, organ dosimetry
first 2 weeks
pharmacokinetics (PK), antigenicity,
first 12 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
multiple dose levelsEXPERIMENTAL1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.
Multi Dose levelsEXPERIMENTALdifferent doses of 90YhPAM4 will be given only once.

Interventions

NameTypeDescription
IMMU-107 (hPAM4)BIOLOGICAL90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
90Y-hPAM4BIOLOGICALSingle dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male or female patients, \>18 years of age, who are able to understand and give written informed consent. * Histologically or cytologically confirmed pancreatic adenocarcinoma. * Stage III (locally advanced, unresectable) or Stage IV (metastatic) disease, including patients wh...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 248 trials

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Frequently asked questions about IMMU-107

What is IMMU-107 used for?

IMMU-107 is an investigational monoclonal antibody that was studied for the treatment of pancreatic cancer. It was evaluated in a Phase 1 clinical trial in combination with gemcitabine in patients with pancreatic cancer. It is not an approved therapy and remains an investigational agent in clinical development.

Who is developing IMMU-107?

IMMU-107 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company holds the development program for this monoclonal antibody asset in oncology.

What phase is IMMU-107 in?

IMMU-107 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is IMMU-107 in?

IMMU-107 was evaluated in the Phase 1 trial NCT00603863, titled Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer. The trial enrolled 80 patients in the United States and is completed. It was an uncontrolled study without randomization or blinding.

Is IMMU-107 the same as IMMU-107 (hPAM4)?

Yes. IMMU-107 is also known as IMMU-107 (hPAM4). The hPAM4 designation refers to the humanized PAM4 monoclonal antibody component of the agent, which was studied in pancreatic cancer in combination with gemcitabine.