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MGCD516

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 6, 2023

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 Enrollment193
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02219711Phase 1/1b Study of MGCD516 in Patients With Advanced CancerPHASE1 COMPLETED 193 — — Aug 1, 2014Apr 27, 2022Mar 6, 202343 United States, South Korea
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Study Endpoints
Primary Endpoints
Type of dose limiting adverse event
Up to 3 weeks on treatment
Area under the plasma concentration versus time curve (AUC) of MGCD516
Up to 72 hours
Peak Plasma Concentration (Cmax) of MGCD516
Up to 72 hours
Secondary Endpoints
Kind of metabolites of MGCD516 in blood plasma
Up to 9 weeks on treatment
Concentration of selected marker proteins in blood plasma
Up to 9 weeks on treatment
Percent of patients having objective disease response to treatment
Up to 1 year on treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MGCD516EXPERIMENTALMGCD516 oral capsule, administered in escalating doses in Phase 1, beginning with daily dosing and exploring other regimens as necessary, in 21 or 28 days cycles
Interventions
NameTypeDescription
MGCD516DRUGMGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites43

Inclusion Criteria: * Metastatic or unresectable solid tumor malignancy * Standard treatment is not available * Adequate bone marrow and organ function Exclusion Criteria: * History of a significant cardiovascular illness * Prolonged corrected QT (QTc) interval * Left ventricular ejection fractio...

Countries:United StatesSouth Korea
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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