A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
IMFINZI-subQ
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
2 other identifiers
interventional
40
5 countries
19
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2026
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
April 17, 2026
April 1, 2026
1.4 years
January 30, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the concentration-time curve
To characterise the AUC of SC durvalumab.
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Observed lowest concentration before the next dose is administered (Ctrough)
To characterise the Ctrough of SC durvalumab
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Secondary Outcomes (10)
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Maximum observed concentration (Cmax)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Time to reach maximum concentration following drug administration (tmax)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Terminal elimination half-life (t1/2λz)
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Total body clearance/apparent total body clearance (CL[/F])
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
- +5 more secondary outcomes
Study Arms (3)
Part 1: SC Durvalumab DL1
EXPERIMENTALParticipants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Part 1: SC Durvalumab DL2
EXPERIMENTALParticipants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Part 2: Expansion Cohort, SC Durvalumab Dose Level X
EXPERIMENTALParticipants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Interventions
Durvalumab + rHu will be administered subcutaneously.
Durvalumab will be administered intravenously.
Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.
Eligibility Criteria
You may qualify if:
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 12 weeks at enrolment.
- Adequate organ and marrow function.
- Minimum body weight \> 30 kg.
- Part 1 only:
- Locally Advanced Unresectable (Stage III) NSCLC Participants -
- Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).
- Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.
- Have not progressed following definitive concurrent chemoradiation.
- LS-SCLC Participants -
- Histologically or cytologically documented LS-SCLC (Stage I-III).
- Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment.
- Have not progressed following definitive concurrent chemoradiation.
- Part 1 and 2:
- Unresectable HCC Participants -
- +5 more criteria
You may not qualify if:
- Active or prior documented autoimmune disease requiring systemic treatment.
- Uncontrolled infection (including human immunodeficiency virus \[HIV\], hepatitis B or C).
- Prior exposure to immune checkpoint inhibitors.
- Part 1 only:
- Locally Advanced Unresectable (Stage III) NSCLC Participants -
- Mixed SCLC and NSCLC histology.
- Active pneumonitis or interstitial lung disease requiring systemic therapy.
- LS SCLC Participants -
- Mixed SCLC and NSCLC histology.
- Extensive-stage disease.
- History of Grade ≥ 2 pneumonitis.
- Part 1 and 2:
- Unresectable HCC Participants -
- Hepatic encephalopathy.
- Uncontrolled ascites.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Research Site
Fitzroy, 3065, Australia
Research Site
St Albans, 3021, Australia
Research Site
Woolloongabba, 4102, Australia
Research Site
Batumi, 6010, Georgia
Research Site
Tbilisi, 0112, Georgia
Research Site
Tbilisi, 0114, Georgia
Research Site
Brzozów, 36-200, Poland
Research Site
Koszalin, 75-581, Poland
Research Site
Lublin, 20-090, Poland
Research Site
Olsztyn, 10-357, Poland
Research Site
Przemyśl, 37-700, Poland
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Tainan, 73657, Taiwan
Research Site
Taipei, 110, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2026
First Posted
February 6, 2026
Study Start
March 31, 2026
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.