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M200, Carboplatin, Paclitaxel, Bevacizumab

Phase 1

Non-small Cell Lung Cancer | Monoclonal antibody | Oncology |Abbott Laboratories|Last Updated: Apr 27, 2012

Target and mechanism

ModalityMonoclonal antibody

Also known as M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

M200, Carboplatin, Paclitaxel, Bevacizumab · 1 trial · 1 indication

Phase 1 1
NCT00666692A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED7 Analytics
PHASE1COMPLETED
A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab.
Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort

Secondary Endpoints

1) Pharmacokinetics of volociximab 2) Efficacy of volociximab in combination with carboplatin/paclitaxel and bevacizumab.
Throughout study period
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEscalating doses of volociximab at 10, 20, and 30 mg/kg with carboplatin, paclitaxel, and bevacizumab

Interventions

NameTypeDescription
M200 (Volociximab), Carboplatin, Paclitaxel, BevacizumabDRUGVolociximab will be administered via IV infusion once every three week at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels on Day 8 of the first cycle. Volociximab will be given for up to 6 cycles (3 weeks/cycle). Subjects who have stable disease or better and subjects who have disease that is not progressing at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All four drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria * Males and females of at least 18 years of age. * Stage IIIB with pleural effusion or Stage IV non-squamous NSCLC. * Measurable and/or evaluable disease according to RECIST. * No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials

Top 20 of 79 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK24PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Revolution Medicines, Inc.RVMD8PHASE3Daraxonrasib, Elironrasib, Zoldonrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV10PHASE3Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab, ABBV-927
Bristol-Myers Squibb CompanyBMY18PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant
Pfizer Inc.PFE16PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS9PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN6PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
BeyondSpring Inc.BYSI1PHASE3Plinabulin
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Frequently asked questions about M200, Carboplatin, Paclitaxel, Bevacizumab

What is M200 used for in non-small cell lung cancer?

M200 is an investigational monoclonal antibody that was studied in combination with carboplatin, paclitaxel, and bevacizumab as a first-line treatment for advanced non-small cell lung cancer (NSCLC). It was evaluated in a single Phase 1b trial and is not an approved therapy.

What does M200 target?

M200, also known as volociximab, is a monoclonal antibody that targets integrin alpha-5 beta-1. This integrin is involved in cell adhesion and migration. By binding to it, M200 was designed to interfere with processes that support tumor growth and survival.

Who is developing M200?

M200 was developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. The company sponsored the Phase 1b study of M200 in combination with carboplatin, paclitaxel, and bevacizumab for advanced non-small cell lung cancer.

What phase is M200 in?

M200 is in Phase 1 development. It has been evaluated in one completed Phase 1b clinical trial. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is M200 in?

M200 was studied in a single Phase 1b trial, NCT00666692, titled a study of volociximab in combination with carboplatin, paclitaxel, and bevacizumab in first-line advanced non-small cell lung cancer. The trial was completed and enrolled 7 participants in the United States.

Is M200 the same as volociximab?

Yes, M200 is also known as volociximab. The two names refer to the same monoclonal antibody. Volociximab is the international nonproprietary name, while M200 is the development code used by Abbott Laboratories.