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AVE1642

Phase 1

Multiple Myeloma | Small molecule | Oncology |Sanofi|Last Updated: Nov 3, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

AVE1642 · 1 trial · 1 indication

Phase 1 1
NCT01233895Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple MyelomaMultiple Myeloma
COMPLETED26 Analytics
PHASE1COMPLETED
Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

definition of the Selected Dose (SD)
2 years

Selected Dose will be based on the AVE1642 clearance /IGF-1 plateaus and on safety (less than 33% of pts with dose limiting toxicity (DLT)when administered as single agent in a first part of the study. The safety and pharmacokinetics of the regimen in combination with bortezomib will be assessed in the second part of the study

Secondary Endpoints

Assess the efficacy (complete, partial, minimal responses and stabilizations)
2 years
Pharmacokinetic drug interaction between AVE1642 and Velcade (part 2)
Day 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVE1642/ AVE1642 with VelcadeEXPERIMENTAL -

Interventions

NameTypeDescription
AVE1642DRUGFor Part 1, AVE1642 was administered on Day 1 and then every three weeks intra-venously with the dose escalation step starting at 3 mg/kg/infusion with a classical dose escalation schema of 3+3. For Part 2, AVE1642 was administered at doses ranging from 0.5 mg/kg to 12 mg/kg
VelcadeDRUGFor Part 2 ONLY, fixed dose of 1.3 mg/m² administered on Days 1, 4, 8, and 11.
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Eligibility Criteria

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

Inclusion Criteria: * Multiple myeloma confirmed by bone marrow aspirate or biopsy * Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression * Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 o...

Countries:FranceItaly
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about AVE1642

What is AVE1642 used for?

AVE1642 is an investigational small molecule being studied for the treatment of multiple myeloma, a type of blood cancer. It is currently in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for use.

What does AVE1642 target?

AVE1642 is an anti-IGF1R monoclonal antibody, meaning it targets the insulin-like growth factor 1 receptor (IGF1R). By targeting this receptor, the drug aims to interfere with signaling pathways that may promote cancer cell growth in multiple myeloma.

Who makes AVE1642?

AVE1642 is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is listed under the ticker symbol SNY on the stock market.

What phase is AVE1642 in?

AVE1642 is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.

What clinical trials is AVE1642 in?

AVE1642 has one completed clinical trial, identified as NCT01233895, titled 'Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma.' This Phase 1 trial enrolled 26 participants in France and Italy and has been completed.

Is AVE1642 the same as an anti-IGF1R monoclonal antibody?

Yes, AVE1642 is an anti-IGF1R monoclonal antibody. It is designed to target the insulin-like growth factor 1 receptor, which is a protein involved in cell growth and survival. This mechanism is being explored for its potential role in treating multiple myeloma.