Actively Recruiting
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Led by AstraZeneca · Updated on 2026-04-17
40
Participants Needed
19
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).
CONDITIONS
Official Title
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks at enrollment
- Adequate organ and marrow function
- Body weight greater than 30 kg
- For Part 1: Histological or cytological evidence of locally advanced unresectable (Stage III) NSCLC
- For Part 1: At least 2 cycles of platinum-based chemotherapy with concurrent radiation therapy for NSCLC
- For Part 1: No progression after definitive concurrent chemoradiation for NSCLC
- For Part 1: Histological or cytological confirmation of limited-stage small cell lung cancer (Stage I-III)
- For Part 1: Completed 4 cycles of chemotherapy with radiotherapy for LS-SCLC within 1 to 42 days before enrollment
- For Part 1: No progression after definitive concurrent chemoradiation for LS-SCLC
- For Parts 1 and 2: Histopathological confirmation of unresectable hepatocellular carcinoma (HCC)
- For Parts 1 and 2: No prior systemic therapy for unresectable HCC
- For Parts 1 and 2: Not eligible for locoregional therapy for unresectable HCC
- For Parts 1 and 2: Child-Pugh Score class A
- For Parts 1 and 2: Measurable disease by RECIST v1.1
You will not qualify if you...
- Active or prior autoimmune disease requiring systemic treatment
- Uncontrolled infection including HIV, hepatitis B or C
- Prior exposure to immune checkpoint inhibitors
- For Part 1 NSCLC: Mixed SCLC and NSCLC histology
- For Part 1 NSCLC: Active pneumonitis or interstitial lung disease requiring systemic therapy
- For Part 1 LS-SCLC: Mixed SCLC and NSCLC histology
- For Part 1 LS-SCLC: Extensive-stage disease
- For Part 1 LS-SCLC: History of Grade 2 or higher pneumonitis
- For Parts 1 and 2 HCC: Hepatic encephalopathy
- For Parts 1 and 2 HCC: Uncontrolled ascites
- For Parts 1 and 2 HCC: Active gastrointestinal bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Research Site
Fitzroy, Australia, 3065
Not Yet Recruiting
2
Research Site
St Albans, Australia, 3021
Not Yet Recruiting
3
Research Site
Woolloongabba, Australia, 4102
Not Yet Recruiting
4
Research Site
Batumi, Georgia, 6010
Not Yet Recruiting
5
Research Site
Tbilisi, Georgia, 0112
Actively Recruiting
6
Research Site
Tbilisi, Georgia, 0114
Actively Recruiting
7
Research Site
Brzozów, Poland, 36-200
Not Yet Recruiting
8
Research Site
Koszalin, Poland, 75-581
Not Yet Recruiting
9
Research Site
Lublin, Poland, 20-090
Not Yet Recruiting
10
Research Site
Olsztyn, Poland, 10-357
Not Yet Recruiting
11
Research Site
Przemyśl, Poland, 37-700
Not Yet Recruiting
12
Research Site
Seongnam-si, South Korea, 13620
Not Yet Recruiting
13
Research Site
Seoul, South Korea, 03722
Not Yet Recruiting
14
Research Site
Seoul, South Korea, 06351
Actively Recruiting
15
Research Site
Seoul, South Korea, 5505
Actively Recruiting
16
Research Site
Tainan, Taiwan, 73657
Not Yet Recruiting
17
Research Site
Taipei, Taiwan, 110
Not Yet Recruiting
18
Research Site
Taipei, Taiwan, 112
Not Yet Recruiting
19
Research Site
Taoyuan, Taiwan, 333
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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