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AZD0171

Phase 2

Locally Advanced or Metastatic Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Trials Updated: Aug 19, 2026

AZD0171 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Apr 2018

AZD0171 target and mechanism

ModalitySmall molecule

Also known as MSC-1

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment167

FDA Designations

No designations recorded

AZD0171 clinical trials

AZD0171 · 2 trials · 5 indications

Phase 2 1Phase 1 1
NCT04999969Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid TumoursLocally Advanced or Metastatic Solid Tumours
ACTIVE NOT_RECRUITING126 Analytics
PHASE2ACTIVE NOT_RECRUITING
Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
Locally Advanced or Metastatic Solid TumoursUnlock trial analytics

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.

Evaluate the safety and tolerability of MSC-1 and determine the recommended dose for MSC-1 monotherapy for further evaluation in the expansion part of the study
Patients will be evaluated for approximately 6 months or until disease progression

Assessment of frequency \& severity of adverse events

Assess the preliminary anti-tumor activity of MSC-1 monotherapy
Patients will be evaluated for approximately 6 months or until disease progression

Determine objective response rate (ORR)

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).
Dose EscalationEXPERIMENTALMultiple dose levels of MSC-1 treatment once every 3 weeks
Dose ExpansionEXPERIMENTALMSC-1 treatment at the recommended Phase 2 dose once every 3 weeks

Interventions

NameTypeDescription
AZD0171DRUGAZD0171
DurvalumabDRUGDurvalumab
GemcitabineDRUGChemotherapy (Standard-of-Care)
Nab-paclitaxelDRUGChemotherapy (Standard-of-Care)
MSC-1BIOLOGICALhumanized monoclonal antibody for intravenous administration
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Eligibility Criteria

Age Range18 Years to 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)

MEDIUMAug 20, 2026NCT04999969Completion: 2026-06-30 → 2026-11-30
MEDIUMAug 20, 2026NCT04999969Completion: 2026-06-30 → 2026-11-30
MEDIUMAug 20, 2026NCT04999969Completion: 2026-06-30 → 2026-11-30
MEDIUMAug 20, 2026NCT04999969Completion: 2026-06-30 → 2026-11-30

Frequently asked questions about AZD0171

What is AZD0171 used for?

AZD0171 is an investigational small molecule being studied for the treatment of locally advanced or metastatic solid tumours. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes AZD0171?

AZD0171 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.

What phase is AZD0171 in?

AZD0171 is currently in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication.

What clinical trials is AZD0171 in?

AZD0171 is being evaluated in a Phase 2 clinical trial with the identifier NCT04999969. This trial is active but not recruiting participants and is studying the drug in combination with durvalumab and chemotherapy in patients with locally advanced or metastatic solid tumours.

Is AZD0171 the same as durvalumab?

No, AZD0171 is not the same as durvalumab. AZD0171 is a small molecule being studied in combination with durvalumab, which is a separate immunotherapy agent, in a clinical trial for solid tumours.