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AZD2962

Phase 1

Haematologic Neoplasms | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 2, 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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07064122A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)PHASE1 RECRUITING 72Nov 3, 2025Oct 20, 2028Mar 2, 202621 United States, Australia +5
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Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicity (DLT)
From Cycle 1 Day 1 up to end of Cycle 1 (28 Days)

A DLT is defined as an adverse event or abnormal laboratory value occurring during the DLT-evaluation period (first 28 days of treatment). This will be evaluated to assess the safety and tolerability and also to identify optimal biological dose (OBD) of AZD2962.

Number of participants with Adverse events (AEs) and serious AEs
Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)

To assess the safety and tolerability of AZD2962 and also to identify OBD of AZD2962.

Duration of exposure
Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)

To assess the safety and tolerability of AZD2962, and also to identify OBD of AZD2962.

Relative dose intensity
Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)

To assess the safety and tolerability of AZD2962, and also to identify OBD of AZD2962.

Secondary Endpoints
Percentage of participants with Objective response (OR)
First dose up to progression of disease (PD) or last evaluable assessment in the absence of progression, whichever comes first (Approximately 3 Years)
Duration of response (DoR)
First documented response, up to the date of the first documented PD or study end, which ever comes first (Approximately 3 Years)
Time to Response (TTR)
First dose up to PD or last evaluable assessment, whichever comes first (Approximately 3 Years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1- AZD2962 (Monotherapy)EXPERIMENTALParticipants with MDS and dysplastic CMML will receive AZD2962 as monotherapy in a dose escalation pattern.
Interventions
NameTypeDescription
AZD2962DRUGAZD2962 will be administered orally once daily.
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Eligibility Criteria
Age Range18 Years — 110 Years
SexALL
Healthy VolunteersNo
Study Sites21

Key Inclusion Criteria: 1. Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts \< 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatme...

Countries:United StatesAustraliaJapanSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07064122primaryCompletionDate: changed
LOWMay 24, 2026NCT07064122studyFirstPostDate: changed