Trial Outcomes & Findings for Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours (NCT NCT04999969)

Last Updated: 2026-02-03

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

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

Results posted on

2026-02-03

Participant Flow

The study enrolled participants across 39 sites in 4 countries. The enrollment period began on December 10, 2021, and the analyses presented in this form are based on clinical data lock date of November 16, 2024.

Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All the study assessments were performed as per the schedule of assessment.

Participant milestones

Participant milestones
Measure	AZD0171 + Durvalumab + Chemotherapy Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Overall Study STARTED	126
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	85

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD0171 + Durvalumab + Chemotherapy Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Overall Study Death	76
Overall Study Progressive Disease	1
Overall Study Withdrawal by Subject	8

Baseline Characteristics

Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Age, Continuous	63.1 years STANDARD_DEVIATION 9.1 • n=13 Participants
Sex: Female, Male Female	55 Participants n=13 Participants
Sex: Female, Male Male	71 Participants n=13 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=13 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=13 Participants
Race/Ethnicity, Customized Asian	21 Participants n=13 Participants
Race/Ethnicity, Customized White	94 Participants n=13 Participants
Race/Ethnicity, Customized Other	1 Participants n=13 Participants
Race/Ethnicity, Customized Not Reported	6 Participants n=13 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=13 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	110 Participants n=13 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=13 Participants
Race/Ethnicity, Customized Missing	5 Participants n=13 Participants

PRIMARY outcome

Timeframe: 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

Population: Safety set, which included all participants who received any amount of study treatment. As specified in the below data table, in the row entitled, 'Any AE leading to dose reduction of AZD0171', one participant had recorded one reduced dose event of AZD0171 by error. This event was not a dose reduction; but, the study treatment was interrupted due to an AE of infusion related reaction, therefore only partial dose was administered.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE	126 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE possibly related to treatment	123 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE possibly related to AZD0171	99 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE possibly related to Durvalumab	107 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE possibly related to Nab-paclitaxel	123 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE possibly related to Gemcitabine	122 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3	115 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE of >= CTCAE grade 3, possibly related to treatment	90 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE of >= CTCAE grade 3, possibly related to AZD0171	46 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE of >= CTCAE grade 3, possibly related to Durvalumab	45 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE of >= CTCAE grade 3, possibly related to Nab-paclitaxel	82 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE of >= CTCAE grade 3, possibly related to Gemcitabine	84 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE (Serious Adverse Event)	72 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE possibly related to treatment	30 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE possibly related to AZD0171	14 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE possibly related to Durvalumab	17 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE possibly related to Nab-paclitaxel	20 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE possibly related to Gemcitabine	21 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE of >= CTCAE grade 3	70 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE of >= CTCAE grade 3, possibly related to treatment	27 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE of >= CTCAE grade 3, possibly related to AZD0171	11 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE of >= CTCAE grade 3, possibly related to Durvalumab	16 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE of >= CTCAE grade 3, possibly related to Nab-paclitaxel	16 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE of >= CTCAE grade 3, possibly related to Gemcitabine	17 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE with outcome death	15 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE with outcome death, possibly related to treatment	3 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE with outcome death, possibly related to AZD0171	3 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE with outcome death, possibly related to Durvalumab	2 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE with outcome death, possibly related to Nab-paclitaxel	3 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE with outcome death, possibly related to Gemcitabine	3 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of treatment	37 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of AZD0171	32 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of Durvalumab	31 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of Nab-paclitaxel	31 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of Gemcitabine	32 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of treatment, possibly related to treatment	22 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of AZD0171, possibly related to AZD0171	11 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of Durvalumab, possibly related to Durvalumab	12 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of Nab-paclitaxel, possibly related to Nab-paclitaxel	9 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to discontinuation of Gemcitabine, possibly related to Gemcitabine	11 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to drug interruption of treatment	103 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to drug interruption of AZD0171	86 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to drug interruption of Durvalumab	61 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to drug interruption of Nab-paclitaxel	98 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to drug interruption of Gemcitabine	94 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose reduction of treatment	67 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose reduction of AZD0171	1 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose reduction of Durvalumab	0 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose reduction of Nab-paclitaxel	60 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose reduction of Gemcitabine	54 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose modification of treatment	110 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose modification of AZD0171	86 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose modification of Durvalumab	61 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose modification of Nab-paclitaxel	106 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any AE leading to dose modification of Gemcitabine	100 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of treatment	28 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of AZD0171	27 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of Durvalumab	28 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of Nab-paclitaxel	26 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of Gemcitabine	27 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of treatment, possibly related to treatment	13 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of AZD0171, possibly related to AZD0171	7 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of Durvalumab, possibly related to Durvalumab	10 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of Nab-paclitaxel, possibly related to Nab-paclitaxel	5 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to discontinuation of Gemcitabine, possibly related to Gemcitabine	6 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to drug interruption of treatment	36 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to drug interruption of AZD0171	33 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to drug interruption of Durvalumab	24 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to drug interruption of Nab-paclitaxel	34 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to drug interruption of Gemcitabine	35 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose reduction of treatment	2 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose reduction of AZD0171	0 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose reduction of Durvalumab	0 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose reduction of Nab-paclitaxel	2 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose reduction of Gemcitabine	2 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose modification of treatment	36 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose modification of AZD0171	33 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose modification of Durvalumab	24 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose modification of Nab-paclitaxel	34 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to dose modification of Gemcitabine	35 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any SAE leading to hospitalisation	71 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any immune mediated AEs	45 Participants
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) Any infusion reaction AEs	11 Participants

PRIMARY outcome

Timeframe: At 12 months

Population: The ITT set, which included all participants who received any dose of study treatment.

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

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Overall Survival at 12 Months (OS-12)	53.8 Percentage Interval 47.79 to 59.5

SECONDARY outcome

Timeframe: 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).

Population: Response Evaluable Set (RES), which included all participants who had measurable disease at baseline.

The ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) that occurred prior to the initiation of subsequent anti-cancer treatment and prior to progression. The ORR was assessed per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Objective Response Rate (ORR)	34.9 Percentage Interval 29.3 to 40.91

SECONDARY outcome

Timeframe: Up to 16 weeks

Population: The ITT set, which included all participants who received any dose of study treatment.

The DCR is defined as the percentage of participants with a best overall response of confirmed CR or PR, or who had stable disease (SD) maintained for 16 weeks from first dose. DCR was assessed per RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Disease Control Rate (DCR)	65.9 Percentage Interval 59.9 to 71.46

SECONDARY outcome

Timeframe: From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)

Population: The ITT set, which included all participants who received any dose of study treatment.

The DoR is defined as the time from first documented objective response (confirmed CR or confirmed PR) until date of first documented disease progression or death (by any cause in the absence of disease progression). The DoR was assessed per RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Duration of Response (DoR)	7.72 Months Interval 6.439 to 9.462

SECONDARY outcome

Timeframe: From first dose of study intervention until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)

Population: The ITT set, which included all participants who received any dose of study treatment.

The PFS is defined as the time from first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), whichever was earlier. The PFS was analyzed using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Median Progression Free Survival (PFS)	7.33 Months Interval 6.801 to 7.918

SECONDARY outcome

Timeframe: At 4 months

Population: The ITT set, which included all participants who received any dose of study treatment.

The percentage of participants alive and free of progression at 4 months per Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Progression Free Survival at 4 Months (PFS-4)	75.5 Percentage Interval 69.95 to 80.13

SECONDARY outcome

Timeframe: From first dose of study intervention until death (Up to 35 months) or from first dose of study intervention until last evaluable assessment (Up to 35 months)

Population: The ITT set, which included all participants who received any dose of study treatment.

The OS is defined as the time from the start of study intervention to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Median Overall Survival (OS)	13.67 Months Interval 11.565 to 15.639

SECONDARY outcome

Timeframe: Day 1 of each Cycle through Cycle 27 (each cycle was 28 days in length), at end of treatment and at Day 28 follow up (post last dose); up to 35 months

Population: The Pharmacodynamic (PD) set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed "n" refers to the number of participants included in analysis in specific time points.

Mean change from baseline was assessed for serum CA19-9

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Day 28 Follow up	19574.2 Units/milliliter (U/mL) Standard Deviation 114348.1
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 25 Day 01	0.9 Units/milliliter (U/mL) Standard Deviation NA Standard deviation is not calculable due to insufficient number of participants
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 26 Day 01	0 Units/milliliter (U/mL) Standard Deviation NA Standard deviation is not calculable due to insufficient number of participants
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 27 Day 01	0 Units/milliliter (U/mL) Standard Deviation NA Standard deviation is not calculable due to insufficient number of participants
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) End of treatment	-471.3 Units/milliliter (U/mL) Standard Deviation 145796.2
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 01 Day 01	0.0 Units/milliliter (U/mL) Standard Deviation 0.0
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 02 Day 01	-12717.2 Units/milliliter (U/mL) Standard Deviation 95596.8
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 03 Day 01	-17463.4 Units/milliliter (U/mL) Standard Deviation 99400.5
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 04 Day 01	-19283.0 Units/milliliter (U/mL) Standard Deviation 106081.2
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 05 Day 01	-19823.2 Units/milliliter (U/mL) Standard Deviation 109490.0
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 06 Day 01	-21974.6 Units/milliliter (U/mL) Standard Deviation 115724.1
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 07 Day 01	-25249.6 Units/milliliter (U/mL) Standard Deviation 124848.3
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 08 Day 01	-26902.4 Units/milliliter (U/mL) Standard Deviation 129722.0
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 09 Day 01	-12230.2 Units/milliliter (U/mL) Standard Deviation 31705.4
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 10 Day 01	-570.9 Units/milliliter (U/mL) Standard Deviation 29271.1
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 11 Day 01	-3363.4 Units/milliliter (U/mL) Standard Deviation 6647.6
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 12 Day 01	-3469.5 Units/milliliter (U/mL) Standard Deviation 6766.1
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 13 Day 01	-2674.8 Units/milliliter (U/mL) Standard Deviation 6895.7
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 14 Day 01	-3100.1 Units/milliliter (U/mL) Standard Deviation 6768.7
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 15 Day 01	-1229.7 Units/milliliter (U/mL) Standard Deviation 2027.1
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 16 Day 01	-1346.8 Units/milliliter (U/mL) Standard Deviation 2040.8
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 17 Day 01	-1470.2 Units/milliliter (U/mL) Standard Deviation 2171.6
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 18 Day 01	-1867.5 Units/milliliter (U/mL) Standard Deviation 2666.0
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 19 Day 01	-1868.8 Units/milliliter (U/mL) Standard Deviation 2691.3
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 20 Day 01	-1928.7 Units/milliliter (U/mL) Standard Deviation 3255.2
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 21 Day 01	-1830.8 Units/milliliter (U/mL) Standard Deviation 2663.2
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 22 Day 01	-1903.7 Units/milliliter (U/mL) Standard Deviation 3244.6
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 23 Day 01	-1854.3 Units/milliliter (U/mL) Standard Deviation 3240.4
Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) Cycle 24 Day 01	-2764.5 Units/milliliter (U/mL) Standard Deviation 3909.6

SECONDARY outcome

Timeframe: Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months

Population: Immunogenicity set, which included all participants who received at least one dose of investigational product (IP) with at least one reportable immunogenicity assessment. The number analyzed "n" refers to the number of participants included in analysis of specific ADA category as mentioned below, \[a\] Participants with ADA result at baseline and/or post-baseline \[b\] Participants with ADA result at baseline and ≥1 post-baseline \[c\] Participants with ADA result at baseline only.

Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum ADA positive at baseline and/or post-baseline (ADA prevalence) (a)	2 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum Treatment Emergent-ADA positive AZD0171	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum Treatment-induced ADA positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum Treatment-boosted ADA positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum Both baseline and post-baseline positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum Only baseline positive (c)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum ADA persistently positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum ADA transiently positive (b)	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months

Population: Immunogenicity set, which included all participants who received at least one dose of IP with at least one reportable immunogenicity assessment. The number analyzed "n" refers to the number of participants included in analysis of specific ADA category as mentioned below, \[a\] Number of participants with ADA result at baseline and/or post-baseline \[b\] Number of participants with ADA result at baseline and ≥1 post-baseline \[c\] Number of participants with ADA result at baseline only.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum ADA positive at baseline and/or post-baseline (ADA prevalence) (a)	8 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum Treatment Emergent-ADA positive (ADA incidence) (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum Treatment-induced ADA positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum Treatment-boosted ADA positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum Both baseline and post-baseline positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum Only baseline positive (c)	3 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum ADA persistently positive (b)	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum ADA transiently positive (b)	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the noncompartmental analysis (NCA). Additional population PK/PK analyses are available under reference: 39041713.

The maximum concentration of AZD0171 was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=9 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Maximum Observed Plasma Concentration (Cmax) of AZD0171 Cycle 01 Day 01	395.4 microgram/mililiter (ug/mL) Geometric Coefficient of Variation 16.84
Maximum Observed Plasma Concentration (Cmax) of AZD0171 Cycle 04 Day 01	694.6 microgram/mililiter (ug/mL) Geometric Coefficient of Variation 31.62

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The Cmax of Nab-paclitaxel was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=6 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel Cycle 01 Day 15	1996 nanogram/mililiter (ng/ml) Geometric Coefficient of Variation 176.4
Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel Cycle 04 Day 15	1113 nanogram/mililiter (ng/ml) Geometric Coefficient of Variation 553.2

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The AUCinf of AZD0171 was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=9 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD0171	56570 h*ug/mL Geometric Coefficient of Variation 77.33

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The AUClast of AZD0171 was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=9 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD0171 AUClast Cycle 01 Day 01	38600 h*ug/mL Geometric Coefficient of Variation 87.50
Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD0171 AUClast Cycle 04 Day 01	66290 h*ug/mL Geometric Coefficient of Variation 44.47

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The AUClast of Nab-paclitaxel was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=6 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel AUClast Cycle 01 Day 15	3992 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 63.70
Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel AUClast Cycle 04 Day 15	2853 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 107.7

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The AUCtau of AZD0171 was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=9 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of AZD0171 AUCtau Cycle 04 Day 01	81760 hourmicrogram/milliliter (hug/mL) Geometric Coefficient of Variation 14.11
Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of AZD0171 AUCtau Cycle 01 Day 01	43770 hourmicrogram/milliliter (hug/mL) Geometric Coefficient of Variation 55.76

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The AUCtau of Nab-paclitaxel was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=6 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of Nab-paclitaxel AUCtau Cycle 01 Day 15	4550 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 54.03
Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of Nab-paclitaxel AUCtau Cycle 04 Day 15	3302 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 98.07

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 and Day 1 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The CL of AZD0171 was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=9 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Clearance (CL) of AZD0171 Cycle 01 Day 01	0.02651 Liter/hour (L/h) Geometric Coefficient of Variation 77.33
Clearance (CL) of AZD0171 Cycle 04 Day 01	0.01835 Liter/hour (L/h) Geometric Coefficient of Variation 14.11

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)

Population: PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The CL of Nab-paclitaxel was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=6 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Clearance (CL) of Nab-paclitaxel Cycle 4 Day 15	67.13 Liter/hour/meter square (L/h/m**2) Geometric Coefficient of Variation 99.70
Clearance (CL) of Nab-paclitaxel Cycle 1 Day 15	51.37 Liter/hour/meter square (L/h/m**2) Geometric Coefficient of Variation 67.48

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The t1/2λz of AZD0171 was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=9 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Terminal Elimination Half-life (t1/2λz) of AZD0171 Cycle 01 Day 01	127.4 Hours Geometric Coefficient of Variation 77.48
Terminal Elimination Half-life (t1/2λz) of AZD0171 Cycle 04 Day 01	188.2 Hours Geometric Coefficient of Variation 6.567

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)

Population: The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

The t1/2λz of Nab-paclitaxel was determined.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=6 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Terminal Elimination Half-life (t1/2λz) of Nab-paclitaxel Cycle 1 Day 15	7.353 Hours Geometric Coefficient of Variation 85.14
Terminal Elimination Half-life (t1/2λz) of Nab-paclitaxel Cycle 4 Day 15	9.509 Hours Geometric Coefficient of Variation 20.20

SECONDARY outcome

Timeframe: In cycle 3 (each cycle was 28 days in length), subsequent to the first disease assessment scan conducted at roughly 8 weeks.

Population: The PD set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed "n" refers to the number of participants included in analysis in specific time points.

The changes in CD8+ T cell tumour infiltration (on-treatment during cycle 3 minus baseline) associated with AZD0171 treatment in combination with durvalumab and chemotherapy was assessed in participants with 1L metastatic pancreatic ductal adenocarcinoma.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=23 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region Central tumor region	2.86 Cells/millimeter square Standard Deviation 378.12
Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region Central tumor region - within Pan-cytokeratin (PanCK)- Tumor Stroma Area	-10.66 Cells/millimeter square Standard Deviation 460.92
Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region Central tumor region- within PanCK+ Carcinoma Cell Compartment	-25.68 Cells/millimeter square Standard Deviation 329.00

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 1 and Day 15, Cycle 5Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1 (each cycle is 28 days in length)

Population: The PD set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713.

Serum concentration of LIF bound to AZD0171 (total LIF) was assessed.

Outcome measures

Outcome measures
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 Participants Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 02 Day 01	195.5 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 85.89
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 01 Day 01	82.01 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 55.91
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 01 Day 15	284.6 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 93.92
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 02 Day 15	174.9 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 69.12
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 03 Day 01	201.4 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 106.4
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 03 Day 15	169.2 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 63.66
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 04 Day 01	166.2 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 59.66
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 04 Day 15	139.5 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 71.98
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 05 Day 01	169.2 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 71.97
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 06 Day 01	182.5 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 96.65
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 07 Day 01	310.0 picogram/millilitre (pg/mL) Geometric Coefficient of Variation NA Standard deviation is not calculable due to insufficient number of participants
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 08 Day 01	187.8 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 94.74
Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time Cycle 11 Day 01	133.2 picogram/millilitre (pg/mL) Geometric Coefficient of Variation 50.24

Adverse Events

AZD0171 + Durvalumab + Chemotherapy

Serious events: 72 serious events

Other events: 126 other events

Deaths: 76 deaths

Serious adverse events

Serious adverse events
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 participants at risk Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Gastrointestinal disorders Colitis	2.4% 3/126 • Number of events 3 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Constipation	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Diarrhoea	2.4% 3/126 • Number of events 3 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Duodenal obstruction	3.2% 4/126 • Number of events 7 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Gastritis erosive	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Intestinal perforation	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Nausea	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Pancreatitis	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Small intestinal haemorrhage	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Blood and lymphatic system disorders Anaemia	2.4% 3/126 • Number of events 4 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Small intestinal obstruction	0.79% 1/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Vomiting	2.4% 3/126 • Number of events 4 • 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. All adverse events during the trial are reported.
General disorders Asthenia	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
General disorders Chills	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
General disorders Oedema peripheral	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
General disorders Pyrexia	3.2% 4/126 • Number of events 5 • 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. All adverse events during the trial are reported.
General disorders Sudden death	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Acute hepatic failure	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Biliary obstruction	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Cholangitis	4.0% 5/126 • Number of events 6 • 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. All adverse events during the trial are reported.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Cholangitis acute	0.79% 1/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Hepatic failure	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Hepatitis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Hyperbilirubinaemia	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Hypertransaminasaemia	2.4% 3/126 • Number of events 3 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Immune-mediated hepatitis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Hepatobiliary disorders Jaundice cholestatic	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Infections and infestations Appendicitis perforated	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Bacteraemia	2.4% 3/126 • Number of events 3 • 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. All adverse events during the trial are reported.
Infections and infestations Biliary tract infection	3.2% 4/126 • Number of events 5 • 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. All adverse events during the trial are reported.
Blood and lymphatic system disorders Thrombocytopenia	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Covid-19	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Catheter site infection	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Clostridium difficile colitis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Device related infection	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Gastroenteritis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Haemophilus infection	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Hepatic infection	2.4% 3/126 • Number of events 3 • 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. All adverse events during the trial are reported.
Infections and infestations Liver abscess	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Necrotising fasciitis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Pancreatic abscess	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Cardiac disorders Cardiac failure	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Pharyngitis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Infections and infestations Pneumonia	4.8% 6/126 • Number of events 6 • 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. All adverse events during the trial are reported.
Infections and infestations Pneumonia aspiration	0.79% 1/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Infections and infestations Sepsis	11.1% 14/126 • Number of events 15 • 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. All adverse events during the trial are reported.
Infections and infestations Septic shock	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Infections and infestations Urosepsis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Injury, poisoning and procedural complications Fall	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Injury, poisoning and procedural complications Infusion related reaction	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Decreased appetite	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Dehydration	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Cardiac disorders Left ventricular failure	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hyperglycaemia	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hyponatraemia	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Malnutrition	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Nervous system disorders Cerebrovascular accident	2.4% 3/126 • Number of events 3 • 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. All adverse events during the trial are reported.
Nervous system disorders Toxic encephalopathy	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Psychiatric disorders Confusional state	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Renal and urinary disorders Acute kidney injury	4.0% 5/126 • Number of events 5 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Cardiac disorders Pericardial effusion	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 5/126 • Number of events 5 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.8% 6/126 • Number of events 6 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Vascular disorders Deep vein thrombosis	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Vascular disorders Hypertensive urgency	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Vascular disorders Orthostatic hypotension	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Vascular disorders Shock	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Cardiac disorders Sinus tachycardia	0.79% 1/126 • Number of events 1 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Abdominal pain	1.6% 2/126 • Number of events 2 • 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. All adverse events during the trial are reported.

Other adverse events

Other adverse events
Measure	AZD0171 + Durvalumab + Chemotherapy n=126 participants at risk Participants received AZD0171 (intravenous \[IV\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.
Blood and lymphatic system disorders Anaemia	49.2% 62/126 • Number of events 99 • 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. All adverse events during the trial are reported.
Blood and lymphatic system disorders Leukocytosis	5.6% 7/126 • Number of events 7 • 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. All adverse events during the trial are reported.
Infections and infestations COVID-19	10.3% 13/126 • Number of events 13 • 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. All adverse events during the trial are reported.
Infections and infestations Candida infection	5.6% 7/126 • Number of events 7 • 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. All adverse events during the trial are reported.
Infections and infestations Urinary tract infection	9.5% 12/126 • Number of events 21 • 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. All adverse events during the trial are reported.
Blood and lymphatic system disorders Neutropenia	21.4% 27/126 • Number of events 59 • 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. All adverse events during the trial are reported.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 21/126 • Number of events 37 • 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. All adverse events during the trial are reported.
Endocrine disorders Hypothyroidism	5.6% 7/126 • Number of events 7 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Decreased appetite	34.1% 43/126 • Number of events 60 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Dehydration	11.9% 15/126 • Number of events 21 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hyperglycaemia	10.3% 13/126 • Number of events 14 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hypoalbuminaemia	7.9% 10/126 • Number of events 11 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hypokalaemia	13.5% 17/126 • Number of events 25 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hypomagnesaemia	10.3% 13/126 • Number of events 21 • 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. All adverse events during the trial are reported.
Metabolism and nutrition disorders Hyponatraemia	8.7% 11/126 • Number of events 12 • 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. All adverse events during the trial are reported.
Psychiatric disorders Insomnia	11.9% 15/126 • Number of events 17 • 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. All adverse events during the trial are reported.
Nervous system disorders Dizziness	18.3% 23/126 • Number of events 29 • 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. All adverse events during the trial are reported.
Nervous system disorders Dysgeusia	27.0% 34/126 • Number of events 36 • 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. All adverse events during the trial are reported.
Nervous system disorders Headache	14.3% 18/126 • Number of events 20 • 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. All adverse events during the trial are reported.
Nervous system disorders Neuropathy peripheral	19.0% 24/126 • Number of events 25 • 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. All adverse events during the trial are reported.
Nervous system disorders Neurotoxicity	7.1% 9/126 • Number of events 13 • 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. All adverse events during the trial are reported.
Nervous system disorders Peripheral motor neuropathy	5.6% 7/126 • Number of events 7 • 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. All adverse events during the trial are reported.
Nervous system disorders Peripheral sensory neuropathy	32.5% 41/126 • Number of events 44 • 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. All adverse events during the trial are reported.
Cardiac disorders Sinus tachycardia	5.6% 7/126 • Number of events 8 • 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. All adverse events during the trial are reported.
Vascular disorders Deep vein thrombosis	6.3% 8/126 • Number of events 8 • 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. All adverse events during the trial are reported.
Vascular disorders Hypertension	11.9% 15/126 • Number of events 19 • 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. All adverse events during the trial are reported.
Vascular disorders Hypotension	12.7% 16/126 • Number of events 17 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Cough	12.7% 16/126 • Number of events 17 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.3% 23/126 • Number of events 31 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.3% 13/126 • Number of events 15 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.1% 9/126 • Number of events 9 • 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. All adverse events during the trial are reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.6% 7/126 • Number of events 8 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Abdominal distension	5.6% 7/126 • Number of events 7 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Abdominal pain	32.5% 41/126 • Number of events 52 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Abdominal pain upper	5.6% 7/126 • Number of events 8 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Constipation	24.6% 31/126 • Number of events 39 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Diarrhoea	57.9% 73/126 • Number of events 126 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Dry mouth	7.9% 10/126 • Number of events 12 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Dyspepsia	7.1% 9/126 • Number of events 10 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.3% 8/126 • Number of events 9 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Nausea	54.8% 69/126 • Number of events 110 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Stomatitis	12.7% 16/126 • Number of events 23 • 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. All adverse events during the trial are reported.
Gastrointestinal disorders Vomiting	32.5% 41/126 • Number of events 77 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Alopecia	35.7% 45/126 • Number of events 48 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Dermatitis acneiform	13.5% 17/126 • Number of events 18 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Erythema	6.3% 8/126 • Number of events 9 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Pruritus	20.6% 26/126 • Number of events 29 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Rash	9.5% 12/126 • Number of events 16 • 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. All adverse events during the trial are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.6% 26/126 • Number of events 34 • 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. All adverse events during the trial are reported.
Musculoskeletal and connective tissue disorders Arthralgia	12.7% 16/126 • Number of events 17 • 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. All adverse events during the trial are reported.
Musculoskeletal and connective tissue disorders Back pain	6.3% 8/126 • Number of events 8 • 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. All adverse events during the trial are reported.
Musculoskeletal and connective tissue disorders Muscular weakness	11.9% 15/126 • Number of events 17 • 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. All adverse events during the trial are reported.
Musculoskeletal and connective tissue disorders Myalgia	12.7% 16/126 • Number of events 21 • 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. All adverse events during the trial are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	11.9% 15/126 • Number of events 18 • 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. All adverse events during the trial are reported.
General disorders Asthenia	29.4% 37/126 • Number of events 77 • 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. All adverse events during the trial are reported.
General disorders Chills	9.5% 12/126 • Number of events 17 • 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. All adverse events during the trial are reported.
General disorders Fatigue	50.0% 63/126 • Number of events 90 • 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. All adverse events during the trial are reported.
General disorders Influenza like illness	7.9% 10/126 • Number of events 11 • 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. All adverse events during the trial are reported.
General disorders Mucosal inflammation	8.7% 11/126 • Number of events 11 • 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. All adverse events during the trial are reported.
General disorders Oedema peripheral	38.1% 48/126 • Number of events 75 • 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. All adverse events during the trial are reported.
General disorders Pyrexia	43.7% 55/126 • Number of events 126 • 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. All adverse events during the trial are reported.
Investigations Alanine aminotransferase increased	30.2% 38/126 • Number of events 54 • 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. All adverse events during the trial are reported.
Investigations Aspartate aminotransferase increased	25.4% 32/126 • Number of events 51 • 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. All adverse events during the trial are reported.
Investigations Blood alkaline phosphatase increased	5.6% 7/126 • Number of events 8 • 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. All adverse events during the trial are reported.
Investigations Gamma-glutamyltransferase increased	9.5% 12/126 • Number of events 12 • 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. All adverse events during the trial are reported.
Investigations Neutrophil count decreased	33.3% 42/126 • Number of events 80 • 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. All adverse events during the trial are reported.
Investigations Platelet count decreased	15.1% 19/126 • Number of events 33 • 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. All adverse events during the trial are reported.
Investigations Weight decreased	15.9% 20/126 • Number of events 24 • 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. All adverse events during the trial are reported.
Investigations White blood cell count decreased	10.3% 13/126 • Number of events 19 • 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. All adverse events during the trial are reported.
Injury, poisoning and procedural complications Fall	6.3% 8/126 • Number of events 10 • 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. All adverse events during the trial are reported.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca.
Publication restrictions are in place

Restriction type: OTHER