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90Y-hPAM4

Phase 3

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

90Y-hPAM4 development status

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

90Y-hPAM4 target and mechanism

ModalityMonoclonal antibody

Also known as 111-IN-hPAM4, MUC-1 antibody, IMMU-107 (hPAM4), hPAM4, IMMU-107, 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

90Y-hPAM4 clinical trials

90Y-hPAM4 · 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 90Y-hPAM4

What is 90Y-hPAM4 used for in pancreatic cancer?

90Y-hPAM4 is an investigational monoclonal antibody being studied for the treatment of pancreatic cancer. It is a radiolabeled antibody designed to deliver radiation directly to cancer cells. As of the available data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.

What does 90Y-hPAM4 target?

90Y-hPAM4 is a monoclonal antibody that targets a specific antigen associated with pancreatic cancer cells. The antibody is labeled with the radioisotope yttrium-90, which delivers targeted radiation to the tumor. This approach aims to concentrate the therapeutic effect at the cancer site while sparing normal tissues.

Who is developing 90Y-hPAM4?

90Y-hPAM4 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 1 clinical trials for pancreatic cancer, and its development is part of Gilead's oncology pipeline.

What phase is 90Y-hPAM4 in?

90Y-hPAM4 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 1 trial was designed to evaluate the safety and efficacy of different doses of the drug in patients with pancreatic cancer.

What clinical trials is 90Y-hPAM4 in?

90Y-hPAM4 has one completed clinical trial registered under NCT00597129, titled 'Safety and Efficacy Study of 90Y-hPAM4 at Different Doses.' This Phase 1 study enrolled 21 participants with pancreatic cancer in the United States. The trial was not randomized or blinded and did not use a control group.