Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chem… (NCT04999969) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
United States126 participantsStarted 2021-12-10
Plain-language 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).
Who can participate
Age range18 Years – 130 Years
SexALL
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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, h…
What they're measuring
1
Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs)
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