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M200, Carboplatin, Paclitaxel

Phase 1

Non-small Cell Lung Cancer | Monoclonal antibody | Oncology |AbbVie Inc.|Last Updated: Nov 21, 2017

Target and mechanism

ModalityMonoclonal antibody

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

M200, Carboplatin, Paclitaxel · 2 trials · 2 indications

Phase 1 2
NCT00654758A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED33 Analytics
NCT00635193Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)Ovarian Cancer, Primary Peritoneal Cancer
COMPLETED138 Analytics
PHASE1COMPLETED
A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)
Non-small Cell Lung CancerUnlock trial analytics
PHASE1COMPLETED
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
Ovarian Cancer, Primary Peritoneal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin and paclitaxel
Dose escalation phase of the trial
To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
50-57 days

Secondary Endpoints

Pharmacokinetics of volociximab
Approximately 2.5 years
Efficacy of volociximab in combination with carboplatin/paclitaxel
Approximately 2.5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEscalating doses of volociximab at 10, 20, and 30 (or 15) mg/kg with carboplatin and paclitaxel.
Cohort 1OTHERThree subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk
Cohort 2OTHERliposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk
Group AOTHERliposomal doxorubicin, 40 mg/m2 q4wk
Group BOTHERliposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)
Group COTHERliposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)

Interventions

NameTypeDescription
M200 (Volociximab), Carboplatin, PaclitaxelDRUGVolociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease 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 three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
M200 (Volociximab)DRUG7.5 mg/kg, IV infusion every week until disease progression
Liposomal DoxorubicinDRUG40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria 1. Males and females at least 18 years of age. 2. Stage IIIB or IV or recurrent NSCLC. 3. Measurable and/or evaluable disease according to RECIST. 4. No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy for early stage disease mus...

Countries:United StatesAustraliaBelgiumItalyPolandRussiaSpainSwedenSwitzerland
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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

What is M200 (Volociximab) used for?

M200, also known as volociximab, has been studied in oncology for advanced non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It was evaluated in combination with carboplatin and paclitaxel in first-line NSCLC and with liposomal doxorubicin in ovarian and primary peritoneal cancers. It is an investigational monoclonal antibody and is not approved for any indication.

What does M200 (Volociximab) target?

M200 (volociximab) is a monoclonal antibody. No molecular target is specified in the available information, so its precise mechanism of action cannot be described here. It was developed as an oncology therapeutic and studied in combination with chemotherapy agents such as carboplatin, paclitaxel, and liposomal doxorubicin.

Who is developing M200 (Volociximab)?

M200 (volociximab) was developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The company sponsored the clinical trials evaluating M200 in combination with carboplatin and paclitaxel for non-small cell lung cancer and with liposomal doxorubicin for ovarian and primary peritoneal cancers.

What phase is M200 (Volociximab) in?

M200 (volociximab) is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The clinical program includes completed Phase 1 trials in non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer.

What clinical trials is M200 (Volociximab) in?

M200 (volociximab) has been studied in two completed Phase 1 trials. NCT00654758 evaluated M200 with carboplatin and paclitaxel in first-line advanced non-small cell lung cancer and enrolled 33 patients. NCT00635193 evaluated M200 with liposomal doxorubicin in ovarian and primary peritoneal cancer and enrolled 138 patients across multiple countries.

Is M200 the same as Volociximab?

Yes, M200 is also known as volociximab. The names refer to the same monoclonal antibody developed by AbbVie Inc. for oncology indications including non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It has been investigated in Phase 1 clinical trials in combination with chemotherapy.