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IMMU-107

Phase 1

Pancreatic Cancer | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 16, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00603863Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic CancerPHASE1 COMPLETED 80Jan 1, 2008Dec 1, 2013Aug 16, 202111 United States
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Study Endpoints
Primary Endpoints
safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
over 12 weeks
Secondary Endpoints
Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc.
over 5 years
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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.
Interventions
NameTypeDescription
IMMU-107 (hPAM4)BIOLOGICAL90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
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Eligibility Criteria
Age Range18 Years — 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 186 trials
CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine, Zimberelimab, Etrumadenant
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Pfizer Inc.PFE9PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, ponsegromab
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine, Telisotuzumab adizutecan, Fluorouracil, Folinic acid/ Leucovorina
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel, BMS-986340, BMS-936558-01
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP, IMM-1-104 Monotherapy
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
BioNTech SE Sponsored ADRBNTX2PHASE2Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX, Autogene cevumeran
Agenus Inc.AGEN5PHASE2Botensilimab, Gemcitabine, Nab-paclitaxel, AGEN1423, Balstilimab
Eli Lilly and CompanyLLY7PHASE1LY4101174, LY4066434., Cetuximab, Nab paclitaxel, Gemcitabine
Merck & Co., Inc.MRK2PHASE2Belzutifan, Sacituzumab tirumotecan, Fluorouracil, Leucovorin or levoleucovorin, Cisplatin
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822, MRG007, JAB-3312
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
ImmunityBio IncIBRX2PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
Candel Therapeutics, Inc.CADL1PHASE2Aglatimagene besadenovec
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pemigatinib, Retifanlimab
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