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Demcizumab

Phase 2

Pancreatic Cancer | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Sep 28, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment264

FDA Designations

No designations recorded

Clinical trial landscape

Demcizumab · 5 trials · 4 indications

Phase 2 2Phase 1 3
NCT02289898Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal AdenocarcinomaPancreatic Cancer
COMPLETED207 Analytics
NCT02259582A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung CancerNonsquamous Nonsmall Cell Neoplasm of Lung
COMPLETED82 Analytics
PHASE2COMPLETED
Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Pancreatic CancerUnlock trial analytics
PHASE2COMPLETED
A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
Nonsquamous Nonsmall Cell Neoplasm of LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).

Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.

To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.

Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.

Dose limiting toxicities (DLT) of demcizumab given in combination with pembrolizumab
Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22)

The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab

To the determine the maximum tolerated dose of demcizumab (OMP-21M18) plus carboplatin and pemetrexed
When each patient in the dose cohort reaches Day 56
To determine the maximum tolerated dose of demcizumab (OMP-21M18) when combined with gemcitabine +/- Abraxane®
Until disease progression

Secondary Endpoints

Pharmacokinetics (PK) of demcizumab and pembrolizumab
Plasma sample for Pharmacokinetics (PK) analysis to be obtained on Days 1, 22, 43 then at every other cycle (each cycle is 21 days) until 12 weeks post treatment termination, an average of 1 year
To determine the safety of carboplatin and pemetrexed plus demcizumab (OMP-21M18)
until treatment termination plus 30 days
To determine the rates of immunogenicity of carboplatin and pemetrexed plus demcizumab (OMP-21M18)
Up to 12 weeks post treatment termination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Abraxane® and gemcitabine plus placeboEXPERIMENTALAbraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Abraxane® and gemcitabine plus demcizumab plus placeboEXPERIMENTALAbraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression
Abraxane® and gemcitabine plus demcizumabEXPERIMENTALAbraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression
Arm 1 Pem, carbo, placebo x 4 cyclesPLACEBO_COMPARATORPemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84
Arm 2 Pem, carbo x 4 cycles, one course of demACTIVE_COMPARATORPemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84
Arm 3 pem, carbo, dem x 4 cycles, dem retreatmentACTIVE_COMPARATORPemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg
Demcizumab and PembrolizumabEXPERIMENTALDemcizumab will be administered prior to pembrolizumab
Carboplatin and Pemetrexed plus demcizumabEXPERIMENTALCarboplatin and Pemetrexed plus demcizumab
Pemetrexed plus demcizumabEXPERIMENTALPemetrexed plus demcizumab
Gemcitabine and demcizumab With or Without Abraxane®EXPERIMENTALGemcitabine and demcizumab With or Without Abraxane®

Interventions

NameTypeDescription
DemcizumabDRUGadministered intravenously
Abraxane®DRUGadministered intravenously
gemcitabineDRUGadministered intravenously
PlaceboDRUG -
PemetrexedDRUG -
CarboplatinDRUG -
PembrolizumabDRUGDrug: Pembrolizumab administered 2mg/kg IV every 3 weeks
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: 1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed. 2. Availability of formalin-fixed paraffin-embedded (FFPE) ...

Countries:United StatesAustraliaBelgiumCanadaSpainUnited KingdomItalyNew Zealand
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Competitive Landscape -Pancreatic Cancer 180 trials

Top 20 of 69 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
ImmunityBio IncIBRX2PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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Frequently asked questions about Demcizumab

What is Demcizumab used for?

Demcizumab is an investigational small molecule being developed for oncology indications, including locally advanced or metastatic solid tumors, pancreatic cancer, non-small cell lung cancer, and nonsquamous nonsmall cell neoplasm of the lung. It has been studied in clinical trials for these conditions, though it remains in clinical development and is not approved.

Who makes Demcizumab?

Demcizumab is being developed by Mereo BioPharma Group plc, a biopharmaceutical company traded under the ticker MREO. The company has sponsored clinical trials evaluating Demcizumab in various oncology settings, including pancreatic cancer and non-small cell lung cancer.

What phase is Demcizumab in?

Demcizumab has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not received regulatory approval. The completed trials include Phase 1 studies in solid tumors and pancreatic cancer, and Phase 2 studies in non-small cell lung cancer and pancreatic ductal adenocarcinoma.

What clinical trials is Demcizumab in?

Demcizumab has been studied in four completed clinical trials: NCT01189929 (Phase 1, pancreatic cancer), NCT02259582 (Phase 2, non-small cell lung cancer), NCT02289898 (Phase 2, pancreatic ductal adenocarcinoma), and NCT02722954 (Phase 1b, solid tumors). All trials are completed with no active trials ongoing.

Is Demcizumab the same as OMP-21M18?

Yes, Demcizumab is also known as OMP-21M18. In clinical trial NCT01189929, the study title refers to Demcizumab (OMP-21M18), confirming that these names refer to the same investigational drug being developed by Mereo BioPharma.