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AZD3632

Phase 1

Acute Lymphoblastic Leukaemia | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 19, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07155226Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX OverexpressionPHASE1 RECRUITING 84Jan 9, 2026Feb 15, 2029May 19, 202630 United States, Australia +7
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Study Endpoints
Primary Endpoints
Module 1: Number of participants with dose-limiting toxicity (DLT)
At the end of Cycle 1 (each cycle is 28 days)

Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.

Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs)
Up to 3 years 1 month

Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.

Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs)
Up to 30 days after last dose (approximately 3 years 1 month)

Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed. Adverse events will be defined as treatment-emergent if they have an onset or worsen (by investigator report of a change in intensity) during the study treatment or the safety follow-up period but prior to any subsequent cancer therapy.

Secondary Endpoints
Module 1 and Module 2: Maximum concentration (Cmax) of AZD3632
From Day 1 to 3 years 1 month
Module 1 and Module 2: Time of maximum concentration (Tmax) of AZD3632
From Day 1 to 3 years 1 month
Module 1: Trough concentration (Ctrough) of AZD3632
From Day 1 to 3 years 1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1: AZD3632 dose 1EXPERIMENTALParticipants will receive AZD3632 (dose 1) through the treatment period.
Module 1: AZD3632 dose 2EXPERIMENTALParticipants will receive AZD3632 (dose 2) through the treatment period.
Module 1: AZD3632 dose 3EXPERIMENTALParticipants will receive AZD3632 (dose 3) through the treatment period.
Module 1: AZD3632 dose 4EXPERIMENTALParticipants will receive AZD3632 (dose 4) through the treatment period.
Module 1: AZD3632 dose 5EXPERIMENTALParticipants will receive AZD3632 (dose 5) through the treatment period.
Module 1: AZD3632 dose 6EXPERIMENTALParticipants will receive AZD3632 (dose 6) through the treatment period.
Module 2: AZD3632 + posaconazoleEXPERIMENTALParticipants will receive AZD3632 alone, then will receive AZD3632 in combination with posaconazole through treatment period.
Interventions
NameTypeDescription
AZD3632DRUGAZD3632 will be administered orally.
PosaconazoleDRUGPosaconazole will be administered orally.
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites30

Key Inclusion Criteria: Core criteria: * Adequate organ function. * Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Module 1: * Advanced haematologic malignan...

Countries:United StatesAustraliaCanadaDenmarkGermanyItalyJapanSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07155226primaryCompletionDate: changed
LOWMay 24, 2026NCT07155226studyFirstPostDate: changed