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Vantictumab combined with paclitaxel

Phase 1

Metastatic Breast Cancer | Small molecule | Oncology |Mereo BioPharma Group plc|Last Updated: Sep 9, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

Vantictumab combined with paclitaxel · 1 trial · 1 indication

Phase 1 1
NCT01973309A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast CancerMetastatic Breast Cancer
COMPLETED37 Analytics
PHASE1COMPLETED
A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer
Metastatic Breast Cancer
NCT0197330937
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Study Endpoints

Primary Endpoints

Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).

The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel

Secondary Endpoints

Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vantictumab combined with paclitaxelEXPERIMENTALDrug: vantictumab combined with paclitaxel - administered intravenously

Interventions

NameTypeDescription
Vantictumab combined with paclitaxelDRUGVantictumab combined with paclitaxel will be administered IV.
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Eligibility Criteria

Age Range18 Years to 90 Years
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Signed Informed Consent Form * Age ≥18 years * Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease o Patients with breast cancer overexpressing HER2 are not eligible. * Availability of tumor tissue, either archival FFPE or obt...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Metastatic Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Vantictumab combined with paclitaxel

What is Vantictumab combined with paclitaxel used for?

Vantictumab combined with paclitaxel is an investigational small molecule being studied for the treatment of metastatic breast cancer. It is being developed by Mereo BioPharma Group plc (MREO). The combination has completed a Phase 1 clinical trial in patients with locally recurrent or metastatic breast cancer.

Who makes Vantictumab combined with paclitaxel?

Vantictumab combined with paclitaxel is being developed by Mereo BioPharma Group plc, a biopharmaceutical company listed on the stock exchange under the ticker MREO. The company is conducting clinical research on this combination for the treatment of metastatic breast cancer.

What phase is Vantictumab combined with paclitaxel in?

Vantictumab combined with paclitaxel is in Phase 1 clinical development. A Phase 1 study of this combination in patients with locally recurrent or metastatic breast cancer has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Vantictumab combined with paclitaxel in?

Vantictumab combined with paclitaxel has been studied in one clinical trial, identified as NCT01973309. This was a Phase 1 study titled 'A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer.' The trial enrolled 37 female patients in the United States and has been completed.

Is Vantictumab combined with paclitaxel FDA approved?

Vantictumab combined with paclitaxel is not FDA approved. It is an investigational drug combination that has completed a Phase 1 clinical trial for metastatic breast cancer. The drug remains in clinical development and has not received regulatory approval for any indication.