Clinical Trials in South Korea / NCT04999969
Active, not recruiting
Phase 2
Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
NCT04999969 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Locally Advanced or Metastatic Solid Tumours
Investigational drug(s) / intervention(s)
AZD0171: AZD0171
Durvalumab: Durvalumab
Gemcitabine: Chemotherapy (Standard-of-Care)
Nab-paclitaxel: Chemotherapy (Standard-of-Care)
Study summary
The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).
Eligibility
Inclusion Criteria:
* Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrolment
* Must have a Gustave Roussy Immune Score of 0 or 1
* Participants diagnosed with histologically confirmed metastatic pancreatic adenocarcinoma
* Participants must have at least 1 measurable lesion to be called a target lesion according to RECIST v1.1
* All participants must consent to providing sufficient archival specimen taken during metastatic stage or fresh tumour specimens for tumoural CD8+ T cell testing for enrolment
* Presence of tumoural CD8+ T cells based on a predetermined benchmarked PDAC external sample
* Normal organ and bone marrow function measured within 28 days prior to first dose of study intervention
* Body weight ≥ 35 kg
Exclusion Criteria:
* Symptomatic central nervous system metastasis or any history of leptomeningeal disease or cord compression
* A participant with an already known sensitising mutation or tumour characteristic for pancreatic cancer for which there is a preferred local standard-of-care treatment
* History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
* Any unresolved toxicities ≥ Grade 2 per Common Terminology Criteria for Adverse Events v5.0 from prior therapy (excluding vitiligo, alopecia, controlled diabetes)
* History of solid organ transplantation
* History of active primary immunodeficiency
* Ongoing or an active infection, including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. A negative COVID-19 PCR test taken within 28 days of the start of the study treatment is required.
* Uncontrolled intercurrent illness
* Participants with prior history of myocardial infarction, transient ischemic attack, coronary bypass, or stroke within the past 3 months prior to the first dose of study intervention
* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms
* Active or prior documented autoimmune or inflammatory disorders
* History of another primary malignancy
* Receipt of any conventional or investigational anticancer therapy prior to the scheduled first dose of study intervention
* Prior receipt of any immune-mediated therapy
* Use of immunosuppressive medication within 14 days prior to the first dose of study intervention
* Receipt of live, attenuated vaccine within 28 days prior to the first dose of study intervention (Participants can receive non-live COVID-19 vaccines, at the discretion of the Investigator)
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) — From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months
The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE. - Overall Survival at 12 Months (OS-12) — At 12 months
Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months.
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | La Jolla | California | |
| Research Site | Los Angeles | California | |
| Research Site | Orange | California | |
| Research Site | Ventura | California | |
| Research Site | Atlanta | Georgia | |
| Research Site | Coeur d'Alene | Idaho | |
| Research Site | Boston | Massachusetts | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Grand Rapids | Michigan | |
| Research Site | Buffalo | New York | |
| Research Site | New York | New York | |
| Research Site | Portland | Oregon | |
| Research Site | San Antonio | Texas | |
| Research Site | Charlottesville | Virginia | |
| Research Site | Seattle | Washington | |
| Research Site | Madison | Wisconsin | |
| Research Site | Barrie | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Toronto | Ontario | |
| Research Site | Seongnam-si | South Korea | |
| Research Site | Seongnam-si | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Badalona | Spain | |
| Research Site | Barcelona | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Majadahonda | Spain | |
| Research Site | Pamplona | Spain |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04999969 on ClinicalTrials.gov ↗ ← All trials in South Korea