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S64315 once a week

Phase 1

Acute Myeloid Leukaemia (AML) | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: May 18, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02979366Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic SyndromePHASE1 COMPLETED 38 — — Mar 15, 2017May 11, 2020May 18, 20229 United States, Australia +2
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Study Endpoints
Primary Endpoints
Incidence of DLTs during the first cycle of treatment with single agent S64315
21-day cycle 1
Safety tolerance profile of S64315 assessed by:Incidence and severity of AEs
From first dose until 30 days after the last dose administration
Tolerability: Dose interruptions
From first dose until 30 days after the last dose administration
Tolerability: Dose reductions
From first dose until 30 days after the last dose administration
Tolerability: Dose intensity
From first dose until 30 days after the last dose administration
Secondary Endpoints
Concentration at the end of infusion (C inf) in plasma
D1 and D2 of cycle 1 and 2, D15 and D16 of cycle 1 and D1 from cycle 3 to cycle 6.
Cumulative amount of a compound excreted in the urine (Ae)
only D1 of cycle 1
Preliminary efficacy assessment according to Cheson criteria (adapted for each disease)
From first dose until 30 days after the last dose administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
S64315 (also referred as MIK665) administered once a weekEXPERIMENTAL -
S64315 (also referred as MIK665) administered twice a weekEXPERIMENTAL -
Interventions
NameTypeDescription
S64315 once a weekDRUGS64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours once every week (21- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.
S64315 twice a weekDRUGS64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours twice every week (28- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female aged ≥ 18 years; * Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia (APL, French-American British M3 classification): * with relapsed or refractory disease without establis...

Countries:United StatesAustraliaFranceSpain
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