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AZD0171

Phase 2

Locally Advanced or Metastatic Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 30, 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 Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04999969Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid TumoursPHASE2 ACTIVE NOT_RECRUITING 126 — — Dec 10, 2021Jun 30, 2026Apr 30, 202634 United States, Canada +2
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs)
From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months

The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.

Overall Survival at 12 Months (OS-12)
At 12 months

Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months.

Secondary Endpoints
Objective Response Rate (ORR)
From Cycle 1 Day 1 (each cycle was 28 days in length) until initiation of subsequent anti-cancer treatment and prior to progression (up to 35 months).
Disease Control Rate (DCR)
Up to 16 weeks
Duration of Response (DoR)
From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD0171 + Durvalumab + chemotherapyEXPERIMENTALParticipants will receive AZD0171 (intravenous \[IV\]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).
Interventions
NameTypeDescription
AZD0171DRUGAZD0171
DurvalumabDRUGDurvalumab
GemcitabineDRUGChemotherapy (Standard-of-Care)
Nab-paclitaxelDRUGChemotherapy (Standard-of-Care)
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrolment * Must have a Gustave Roussy Immune Score of 0 or 1 * Participants diagnosed with histologically confirmed metastatic pancreatic adenocarcinoma * Participants must have at least 1 measurable...

Countries:United StatesCanadaSouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04999969primaryCompletionDate: changed
LOWMay 24, 2026NCT04999969studyFirstPostDate: changed