AZD0171 With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumors

Summary

The purpose of this study is to learn more about adding the experimental immunotherapy drugs AZD0171 and durvalumab to the current treatment of chemotherapy (nab-paclitaxel and gemcitabine) for pancreatic cancer. The study also aims to better understand and treat pancreatic cancer and associated health problems. AZD0171 and Durvalumab are a type of anti-cancer drug called immunotherapy. AZD0171 decreases tumor growth by blocking a leukemia inhibitory factor that is linked to tumor growth and spread (metastasis). It also changes the environment in the tumor and allows the immune system to attack cancer cells. Durvalumab targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. The immune system can then attack and kill cancer cells. AZD0171 and Durvalumab will be given to participants through a needle into a vein in the arm (intravenous infusion).

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

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)

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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

Full Title

D8151C00001: A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination with Durvalumab and Chemotherapy in Participants with Locally Advanced or Metastatic Solid Tumors

Details

Disease Type/Condition

Pancreas

Principal Investigator

Chiu, Vi K.

Co-Investigators

Ani Balmanoukian, Inderjit Mehmi, Kristopher Wentzel, Michelle Offner, Omid Hamid

Age Group

Adult

Phase

IRB Number

STUDY00001780