Actively Recruiting
A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours
Led by AstraZeneca · Updated on 2026-05-15
40
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetics and safety of a subcutaneous (under the skin) injection of durvalumab combined with recombinant human hyaluronidase (rHu) in adults with solid tumors. This Phase I multicenter trial aims to find a dose of this subcutaneous combination that produces similar systemic drug exposure as the standard intravenous durvalumab. Participants include those with non-small cell lung cancer, hepatocellular carcinoma, or limited-stage small cell lung cancer. The study has two parts: Part 1 focuses on dose escalation with two planned dose levels of subcutaneous durvalumab plus rHu, followed by intravenous durvalumab at set intervals. Part 2 involves dose expansion in participants with unresectable hepatocellular carcinoma using the dose determined from Part 1. Some participants with unresectable hepatocellular carcinoma may also receive intravenous tremelimumab. Treatments are administered according to assigned dose levels and schedules. Participants will undergo monitoring throughout approximately 17 months, including measuring drug levels in the blood at defined times to assess pharmacokinetics. Researchers will track safety by recording adverse events and dose-limiting toxicities during treatment and follow-up. Assessments include evaluating the lowest drug concentration before dosing and calculating drug exposure over time. The study involves regular visits for drug administration and safety evaluations to understand the body's response to the treatments and monitor participant health.
CONDITIONS
Brief 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 enrolment
- Adequate organ and marrow function
- Minimum body weight greater than 30 kg
- For Part 1, diagnosis of locally advanced unresectable (Stage III) non-small cell lung cancer with prior chemoradiation and no progression
- For Part 1, diagnosis of limited-stage small cell lung cancer (Stage I-III) with prior chemoradiation completed 1 to 42 days before enrolment and no progression
- For Parts 1 and 2, unresectable hepatocellular carcinoma confirmed by histopathology
- No prior systemic therapy for unresectable hepatocellular carcinoma
- Not eligible for locoregional therapy for unresectable hepatocellular carcinoma
- Child-Pugh Score class A for hepatocellular carcinoma
- Measurable disease as defined by RECIST v1.1 for hepatocellular carcinoma
You will not qualify if you...
- Active or prior autoimmune disease requiring systemic treatment
- Uncontrolled infection including HIV, hepatitis B, or hepatitis C
- Prior exposure to immune checkpoint inhibitors
- For Part 1, mixed small cell and non-small cell lung cancer histology
- For Part 1, active pneumonitis or interstitial lung disease requiring systemic therapy
- For limited-stage small cell lung cancer, extensive-stage disease
- History of Grade 2 or higher pneumonitis
- For Parts 1 and 2, hepatic encephalopathy
- Uncontrolled ascites
- Active gastrointestinal bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on dose escalation schedule within Part 1
Participants receive initial dose escalation of subcutaneous durvalumab with rHu followed by intravenous durvalumab at predefined intervals to assess safety and pharmacokinetics.
Multiple visits during dose escalation phase
Duration - Up to approximately 17 months
Participants receive the identified dose level of subcutaneous durvalumab with rHu followed by intravenous durvalumab at predefined intervals for up to approximately 17 months.
Visits at predefined intervals throughout treatment
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
Actively 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
Actively Recruiting
12
Research Site
Seongnam-si, South Korea, 13620
Actively Recruiting
13
Research Site
Seoul, South Korea, 03722
Actively 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
Actively 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
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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