Clinical trial · Interventional
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
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
NCT03394144CI-TRIAL-00039186completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD9150, Durvalumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C1:AZD9150, C2:AZD9150+Durvalumab
- description
- After confirmed safety with Cohort 1, Cohort 2 will open
- interventionNames
- Drug: AZD9150, Durvalumab
Primary outcomes (1)
- 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.
- description
- Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Secondary outcomes (4)
- measure
- Maximum plasma concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNishina 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. PMID 36270753