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TTX-030, nab-paclitaxel and gemcitabine

Phase 2

Pancreatic Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Dec 4, 2024

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment194
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06119217Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC PatientsPHASE2 ACTIVE NOT_RECRUITING 194Mar 25, 2024Jun 1, 2027Dec 4, 202464 United States, Australia +5
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Study Endpoints
Primary Endpoints
Progression-free survival (PFS) - Biomarker Enriched Population
Through study completion, an average of 1 year

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first

Secondary Endpoints
Progression-free survival (PFS) - Overall Population
Through study completion, an average of 1 year
Objective Response Rate (ORR)
Through study completion, an average of 1 year
Duration of Response (DoR)
Through study completion, an average of 1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALTTX-030 plus nab-paclitaxel and gemcitabine
Arm 2EXPERIMENTALTTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Arm 3ACTIVE_COMPARATORNab-Paclitaxel and gemcitabine
Interventions
NameTypeDescription
TTX-030, nab-paclitaxel and gemcitabineCOMBINATION_PRODUCTDose and schedule per protocol
TTX-030, budigalimab, nab-paclitaxel and gemcitabineCOMBINATION_PRODUCTDose and schedule per protocol
Nab-Paclitaxel and gemcitabineCOMBINATION_PRODUCTDose and schedule per protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites64

Abbreviated Inclusion Criteria: 1. Age 18 years or older, is willing and able to provide informed consent 2. Histologically or cytologically confirmed diagnosis of metastatic PDAC. 3. No prior systemic treatment for metastatic disease. 4. Evidence of measurable disease per RECIST 1.1. 5. Appropriat...

Countries:United StatesAustraliaFranceItalySouth KoreaSpainTaiwan
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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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06119217studyFirstPostDate: changed