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NPC-1C/NEO-102

Phase 1

Metastatic Pancreatic Cancer | Small molecule | Oncology |Precision BioSciences, Inc.|Last Updated: Aug 4, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

NPC-1C/NEO-102 · 1 trial · 2 indications

Phase 1 1
NCT01040000QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal CancerMetastatic Pancreatic Cancer
COMPLETED94 Analytics
PHASE1COMPLETED
QUILT-3.019: Phase 2 Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer
Metastatic Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.
10 weeks
Efficacy OS
5 months

Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C (NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor.

Secondary Endpoints

Safety will be assessed by analysis of adverse experiences, clinical laboratory tests, and physical examinations.
10 weeks
Pharmacokinetics and select immune responses to the antibody will be assessed.
10 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NPC-1C/NEO-102EXPERIMENTAL -

Interventions

NameTypeDescription
NPC-1C/NEO-102DRUGSubjects will receive NPC-1C at a dose of 3.0 mg/kg. NPC-1C will be given intravenously (by vein) over approximately 1-6 hours, once every 2 weeks for 4 doses per course. Courses will be repeated in the absence of disease progression or unacceptable toxicity.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites6

INCLUSION CRITERIA: * Age: \>/= 18 * Diagnosis: * Histologically confirmed recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas who have progressed after front line chemotherapy, OR * Histologically confirmed metastatic colorectal adenocarcinoma who have progre...

Countries:United States
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Competitive Landscape -Pancreatic Cancer 179 trials (matched to "Metastatic Pancreatic Cancer")

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 NPC-1C/NEO-102

What is NPC-1C/NEO-102 used for?

NPC-1C/NEO-102 is an investigational small molecule being studied for the treatment of metastatic pancreatic cancer. It is also being evaluated in metastatic colorectal cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes NPC-1C/NEO-102?

NPC-1C/NEO-102 is being developed by Precision BioSciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol DTIL. Precision BioSciences is responsible for the clinical development and potential commercialization of this investigational therapy.

What phase is NPC-1C/NEO-102 in?

NPC-1C/NEO-102 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is still in the early stages of clinical testing to evaluate its safety and potential efficacy.

What clinical trials is NPC-1C/NEO-102 in?

NPC-1C/NEO-102 has been studied in one completed clinical trial, identified as NCT01040010. This trial, titled QUILT-3.019, was a Phase 2 study of the NPC-1C chimeric monoclonal antibody for pancreatic and colorectal cancer. The trial enrolled 94 participants and was conducted in the United States.

Is NPC-1C/NEO-102 the same as NEO-102?

Yes, NPC-1C and NEO-102 refer to the same investigational drug. The drug is identified by both names in clinical development. It is being studied for its potential use in treating metastatic pancreatic cancer and metastatic colorectal cancer.