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BMS-777607

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

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 Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00605618Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 8 — — Mar 1, 2008Mar 1, 2009Jan 25, 20112 Australia
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Study Endpoints
Primary Endpoints
Safety and efficacy assessment including vitals signs, physical assessments, and blood tests
will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months
Tumor assessments
will be conducted every 6 weeks. All assessments will continue for at least 24 months
Secondary Endpoints
Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669
will be assessed once weekly for the first 3 weeks
The effects of BMS-777607 on blood pressure (BP), heart rate (HR)
will be assessed once weekly for the first 3 weeks then every 3 weeks
Effects on electrocardiogram (ECG), PR interval
will be assessed at base line, at week 3 and at end of treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ArmEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-777607DRUGSuspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: Part A: * Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known Part B: * Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on sta...

Countries:Australia
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Competitive Landscape -Other Solid Tumors 9 trials
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Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
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Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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