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monoclonal antibody RAV12

Phase 1

Cancer | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Feb 22, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00101972RAV12 in Treating Patients With Metastatic or Recurrent AdenocarcinomaPHASE1 COMPLETED 53Dec 1, 2004May 1, 2008Feb 22, 20225 United States
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Study Endpoints
Primary Endpoints
Toxicity by CTCAE
Days 1-50
Secondary Endpoints
Maximum tolerated dose
Days 1-50
Pharmacokinetics of RAV12 by serum levels
Days 1, 2, 4, 5, 8, 15, 22, 29, 36, 43, and 50
Immunogenicity by Human Anti-chimeric antibodies
Days 1, 8, 15, 22, and 50
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RAV12EXPERIMENTAL -
Interventions
NameTypeDescription
monoclonal antibody RAV12BIOLOGICALEscalating doses of RAV12 (weekly 0.3, 1.0, 1.5, 3.0, 4.0, 5.0, 6.0 mg/kg or 0.5 mg/kg BIW or TIW; 0.75 mg/kg BIW) for 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma * Metastatic or recurrent disease * Not curable by standard therapies * Must have failed at least 1, but no more than 3, prior therapies for metastatic or recurrent disease * Patients with colorectal or breast adenocarcinoma...

Countries:United States
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