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AZD3470

Phase 1

Advanced Solid Tumors That Are MTAP Deficient | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 11, 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 Enrollment334
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06130553A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid TumorsPHASE1 RECRUITING 334 — — Jan 18, 2024Dec 4, 2028May 11, 202620 United States, Australia +6
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Study Endpoints
Primary Endpoints
All Modules: Incidence of adverse events (AEs) and serious adverse events (SAEs). To determine the RP2D of AZD3470 as monotherapy and in combination with anticancer agents
From time of informed consent to 28 days post last dose of study treatment

Number of participants with AEs and SAEs.

Module 1: Incidence of dose-limiting toxicities (DLT)
From first dose of study treatment until the end of Cycle 1 (each cycle is 21 days)

Incidence of dose-limiting toxicities (DLT) as determined by number of patients with at least 1 dose-limiting toxicity (DLT)

Module 2: Progression Free Survival assessed by the Investigator according to RECIST v1.1
From date of randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

PFS - defined as time from date of randomization until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause.

Secondary Endpoints
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - ORR (Objective Response Rate)
From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - DoR (Duration of Response)
From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - Best percentage change in tumor size
From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1: AZD3470 MonotherapyEXPERIMENTALPart A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470
Module 2: AZD3470 in combination with Dato-DXdEXPERIMENTALVarying doses of AZD3470 in combination with Dato-Dxd
Module 2: Dato-DXd aloneEXPERIMENTALControl arm
Interventions
NameTypeDescription
AZD3470DRUGAZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.
Datopotamab deruxtecanDRUGAZD3470 in combination with Dato-DXd + Dato-Dxd monotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria (All Modules) Participants are ≥ 18 years (or the legal age of consent in the jurisdiction) at the time of signing the informed consent form. Participants are able to provide written informed consent and are willing and able to comply with study procedures. Participants are will...

Countries:United StatesAustraliaChinaFranceJapanNetherlandsSouth KoreaSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06130553Enrollment: 234 → 334
LOWMay 24, 2026NCT06130553studyFirstPostDate: changed