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S65487 and azacitidine

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: May 18, 2026

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 Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04742101Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid LeukemiaPHASE1 COMPLETED 57 — — Mar 10, 2021Mar 27, 2026May 18, 202611 France, Hungary +4
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity (DLT) (phase I part)
Through the end of first cycle (each cycle is 28 days)

DLT assessment at the end of cycle 1

Adverse Event (phase I part)
Through study completion, an average of 3 years ans 5 months

AE recording throughout the study evaluated according to CTCAE v5.0, dose interruptions, reductions, and intensity

Complete Remission (CR) rate (phase II part)
Through study completion, up to 3 years and 5 months

CR rate is defined as the proportion of subjects who achieve complete response. Response is evaluated based on the "'Diagnosis and management of AML in adults: 2022 ELN recommendations from an international expert panel" (Döhner, 2022).

Secondary Endpoints
PharmacoKinetics - maximum Concentration at the End of the infusion (Cinf) (phase I and phase II parts)
Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 (schedule 1, first two cohorts), Cycle 2 Day 8 (from Cohort 3), or Day 15 (first two cohorts)(each cycle is 28 days)
PharmacoKinetics - Area Under the Curve (AUC) (phase I and phase II parts)
Cycle 1 Day 8 to Day 9, Cycle 2 Day 8 to Day 9 (from cohort 3), or Day 15 to Day 16 (first two cohorts)(each cycle is 28 days)
Assessment of anti-leukemic activity of S65487 combined to azacitidine (phase I and phase II parts)
Through study completion, an average of 3 years and 5 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
S65487 with azacitidineEXPERIMENTAL -
Interventions
NameTypeDescription
S65487 and azacitidineDRUGTreatment cycle of combination of S65487 and azacitidine during 4 weeks. Two administration schedules are set up. S65487 will be administered via intravenous (IV) infusion. Azacitidine will be administered via either subcutaneous (SC) or Intravenous (IV) infusion according to local practices.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male or female participant aged ≥ 18 years old * Participants with cytologically confirmed and documented treatment naïve, de novo or secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML includes: * Previous myelodysplastic syndrome transformed * ...

Countries:FranceHungaryPolandSouth KoreaSpainUnited Kingdom
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