Clinical trial NCT03394144: Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-01-09
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.


Eligibility criteria: Key Inclusion Criteria:

* Male and female patients must be at least 20 years of age.
* Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
* Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).
* Adequate organ and marrow function
* Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol

Key Exclusion Criteria:

* Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.
* Patients must have completed any previous cancer-related treatments before enrolment.
* Has active or prior autoimmune disease within the past 2 years
* Has active or prior inflammatory bowel disease or primary immunodeficiency
* Undergone an organ transplant that requires use of immunosuppressive treatment
* Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
* Prior exposure to AZD9150 or any other anti PD (L)1 antibody.

Primary outcomes:
measure: Safety and tolerability in terms of adverse events
timeFrame: From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
measure: Overall response rate
timeFrame: Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
measure: Duration of Response
timeFrame: Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
Study officials:
References:
citation: Nishina T, Fujita T, Yoshizuka N, Sugibayashi K, Murayama K, Kuboki Y. Safety, tolerability, pharmacokinetics and preliminary antitumour activity of an antisense oligonucleotide targeting STAT3 (danvatirsen) as monotherapy and in combination with durvalumab in Japanese patients with advanced solid malignancies: a phase 1 study. BMJ Open. 2022 Oct 21;12(10):e055718. doi: 10.1136/bmjopen-2021-055718.