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AZD4956

Phase 1

Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 26, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07446855Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid TumoursPHASE1 RECRUITING 180Mar 17, 2026Mar 29, 2030May 26, 202618 United States, Australia +4
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Study Endpoints
Primary Endpoints
Parts A and B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
From Screening (Day -28) to follow-up (up to 3.5 years)

To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).

Part B: Progression free survival (PFS)
Up to 3.5 years

PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participants withdraw from study treatment or receive another anti-cancer therapy prior to progression.

Part A - Number of participants with dose-limiting toxicities (DLTs)
Up to 28 days

To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).

Secondary Endpoints
Objective response (OR)
Up to 3.5 years
Duration of response (DoR)
Up to 3.5 years
Best Overall Response (BOR)
Up to 3.5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1 Part A: AZD4956 monotherapy (Dose escalation)EXPERIMENTALParticipants will receive AZD4956 as monotherapy at ascending dose levels.
Module 2 Part A: AZD4956 + saruparib (Dose escalation)EXPERIMENTALParticipants will receive AZD4956 at ascending dose levels in combination with saruparib.
Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparibEXPERIMENTALParticipants will receive AZD4956 in combination with saruparib.
Module 2 Part A Optional PD backfill cohort: Saruparib monotherapyEXPERIMENTALParticipants will receive saruparib monotherapy.
Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparibEXPERIMENTALParticipants with metastatic castrate resistant prostate cancer (mCRPC) will receive AZD4956 in combination with saruparib.
Module 2 Part B: AZD4956 + saruparib (Dose expansion)EXPERIMENTALParticipants will receive AZD4956 in combination with saruparib.
Interventions
NameTypeDescription
AZD4956DRUGAZD4956 will be administered orally.
SaruparibDRUGSaruparib will be administered orally.
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites18

Core Inclusion Criteria: * Documented locally advanced or metastatic solid tumour malignancy. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to screening and first day of dosing. * Minimum life expectancy ≥ 12 weeks. * ...

Countries:United StatesAustraliaJapanSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07446855lastUpdatePostDate: changed
LOWMay 27, 2026NCT07446855lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07446855Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07446855studyFirstPostDate: changed