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90Y-hPAM4

Phase 1

Pancreatic Cancer | Monoclonal antibody | 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 Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

90Y-hPAM4 · 1 trial · 1 indication

Phase 1 1
NCT00597129Safety and Efficacy Study of 90Y-hPAM4 at Different DosesPancreatic Cancer
COMPLETED21 Analytics
PHASE1COMPLETED
Safety and Efficacy Study of 90Y-hPAM4 at Different Doses
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

safety MTD
over the first 12 weeks, then over 2 years

Secondary Endpoints

targeting, biodistribution, organ dosimetry
first 2 weeks
pharmacokinetics (PK), antigenicity,
first 12 weeks
efficacy
over first 12 weeks, then over 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Multi Dose levelsEXPERIMENTALdifferent doses of 90YhPAM4 will be given only once.

Interventions

NameTypeDescription
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 Sites4

Inclusion Criteria: * Male or female patients, \>18 years of age, who are able to understand and give written informed consent. * Histologically or cytologically confirmed, Stage III or IV pancreatic adenocarcinoma. * Patients with Stage III (locally advanced) disease must have documented progressi...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 179 trials

Top 20 of 68 competitors

CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine
Pfizer Inc.PFE7PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
BioNTech SE Sponsored ADRBNTX2PHASE2Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822
Merck & Co., Inc.MRK2PHASE2Belzutifan
Eli Lilly and CompanyLLY7PHASE1LY4101174
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
Agenus Inc.AGEN4PHASE2AGEN1423, Botensilimab, Gemcitabine, Nab-paclitaxel
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
ImmunityBio IncIBRX1PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
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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.