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Nab-paclitaxel

Phase 1

Advanced Pancreatic Cancer | Monoclonal antibody | Oncology |ImmunityBio, Inc.|Last Updated: Jan 27, 2020

Target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Nab-paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT02559674QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-PaclitaxelAdvanced Pancreatic Cancer
COMPLETED8 Analytics
PHASE1COMPLETED
QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-Paclitaxel
Advanced Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of MTD; Phase Ib
9 Months

Determine the maximum tolerated dose (MTD) level and designate the recommended dose level for phase II.

Safety Profile (Number and severity of treatment related AEs); Phase Ib and II
48 Months

Number and severity of treatment related adverse events (AEs) that occur or worsen after the first dose of study treatment

Overall Survival; Phase II
8.5 Months

Determine the 8.5 month overall survival of treated patients

Secondary Endpoints

Objective response rate
72 Months
Duration of response
72 Months
Time to progression
72 Months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxelEXPERIMENTAL -

Interventions

NameTypeDescription
GemcitabineBIOLOGICALIntravenous Infusion; Patients will receive two 4-week treatment cycles consisting of gemcitabine given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.
Nab-paclitaxelBIOLOGICALIntravenous Infusion; Patients will receive two 4-week treatment cycles consisting of nab-paclitaxel given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.
ALT-803BIOLOGICALSubcutaneous Injection; Patients will receive two 4-week cycles consisting of ALT-803 given on Day 2, 9, 16, 30, 37, and 44. Eligible patients may receive up to 10 additional treatment cycles.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of pancreatic cancer. * For dose escalation phase (Phase Ib) distant metastatic disease or unresectable disease and not a candidate for down staging to resection. * For expansion phase (Phase II...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 178 trials (matched to "Advanced Pancreatic Cancer")

Top 20 of 67 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 Nab-paclitaxel

What is Nab-paclitaxel used for in Advanced Pancreatic Cancer?

Nab-paclitaxel is being studied for use in advanced pancreatic cancer. It is an investigational drug currently in Phase 1 clinical development. In the completed trial, it was administered in conjunction with gemcitabine and ALT-803 to patients with advanced pancreatic cancer.

What does Nab-paclitaxel target?

Nab-paclitaxel targets tubulin proteins, specifically TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these molecular targets, which are involved in microtubule dynamics within cells.

Who makes Nab-paclitaxel?

Nab-paclitaxel is being developed by ImmunityBio, Inc., a company traded on the stock exchange under the ticker symbol IBRX. The company is conducting clinical research to evaluate the drug's potential in treating advanced pancreatic cancer.

What phase is Nab-paclitaxel in?

Nab-paclitaxel is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 8 patients with advanced pancreatic cancer.

What clinical trials is Nab-paclitaxel in?

Nab-paclitaxel has been studied in one clinical trial with the identifier NCT02559674, titled 'QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-Paclitaxel'. This Phase 1 trial was completed in the United States and enrolled 8 patients.

Is Nab-paclitaxel the same as ALT-803?

No, Nab-paclitaxel is not the same as ALT-803. In the clinical trial NCT02559674, Nab-paclitaxel was administered in conjunction with gemcitabine and ALT-803, indicating they are distinct agents used together in the treatment regimen for advanced pancreatic cancer.