Solid TumoursPhase 1IMFINZI-subQNCT07391670
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
A Phase 1 study testing SC durvalumab + rHu, IV durvalumab and Tremelimumab in people with Solid Tumours, run by AstraZeneca at 19 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- SC durvalumab + rHu, IV durvalumab and Tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 31 Mar 2026to 30 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
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- 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 -
- Unresectable HCC based on histopathological confirmation.
- No prior systemic therapy for unresectable HCC.
- Must not be eligible for locoregional therapy for unresectable HCC.
- Child-Pugh Score class A.
- Measurable disease as defined by RECIST v1.1.
Who cannot join
- 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.
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- 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.
- Active gastrointestinal (GI) bleeding.
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
19 sites in 5 countries
Poland5 sites, 5 recruiting
- Recruiting
Research Site
Brzozów, 36-200
- Recruiting
Research Site
Koszalin, 75-581
- Recruiting
Research Site
Lublin, 20-090
- Recruiting
Research Site
Olsztyn, 10-357
- Recruiting
Research Site
Przemyśl, 37-700
South Korea4 sites, 4 recruiting
- Recruiting
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 5505
Taiwan4 sites, 2 recruiting
- Recruiting
Research Site
Tainan, 73657
- Recruiting
Research Site
Taipei, 110
- Withdrawn
Research Site
Taipei, 112
- Withdrawn
Research Site
Taoyuan, 333
Australia3 sites
- Withdrawn
Research Site
Fitzroy, 3065
- Withdrawn
Research Site
St Albans, 3021
- Withdrawn
Research Site
Woolloongabba, 4102
Georgia3 sites, 3 recruiting
- Recruiting
Research Site
Batumi, 6010
- Recruiting
Research Site
Tbilisi, 0112
- Recruiting
Research Site
Tbilisi, 0114
About this study
Official title: 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
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).
Read the detailed description
This is a Phase I, multicentre study that will consist of 2 parts -
- Part 1: Dose Escalation
- Part 2: Dose Expansion
Part 1 may include participants with solid tumours - non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or limited-stage small cell lung cancer (LS-SCLC). It will further consist of 2 planned dose levels of SC durvalumab - Dose level 1 (DL1) and Dose level 2 (DL2).
Part 2 will include participants with unresectable HCC. It will be initiated once a dose has been identified based on Part 1.
- Conditions
- Solid Tumours
- Being tested
- SC durvalumab + rHu, IV durvalumab, Tremelimumab
- Keywords
- Pharmacokinetics, Non-small cell lung cancer (Stage III, unresectable), Small cell lung cancer (Limited stage), Hepatocellular carcinoma (Unresectable), Subcutaneous, Human hyaluronidase, Monoclonal antibody, Programmed cell death ligand 1 (PD-L1), Programmed cell death protein 1, Anticancer therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC durvalumab + rHuDrug
Durvalumab + rHu will be administered subcutaneously.
IV durvalumabDrug
Also called MEDI4736
Durvalumab will be administered intravenously.
TremelimumabDrug
Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SC Durvalumab DL1 | Experimental | Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. Receives: Drug: SC durvalumab + rHu; Drug: IV durvalumab; Drug: Tremelimumab |
| Part 1: SC Durvalumab DL2 | Experimental | Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. Receives: Drug: SC durvalumab + rHu; Drug: IV durvalumab; Drug: Tremelimumab |
| Part 2: Expansion Cohort, SC Durvalumab Dose Level X | Experimental | Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. Receives: Drug: SC durvalumab + rHu; Drug: IV durvalumab; Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve
To characterise the AUC of SC durvalumab.
Measured: 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
Measured: 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)
To characterise the AUClast of SC durvalumab.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Maximum observed concentration (Cmax)
To characterise the Cmax of SC durvalumab.
Measured: 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)
To characterise the tmax of SC durvalumab.
Measured: 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)
To characterise the t1/2λz of SC durvalumab.
Measured: 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])
To characterise the CL(/F) of SC durvalumab.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Apparent volume of distribution based on the terminal phase volume (Vz[/F])
To characterise the VZ(/F) of SC durvalumab.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Average drug concentration over a dosing interval (Cavg)
To characterise the Cavg of SC durvalumab.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Serum concentration of durvalumab
To characterise the serum concentration of SC durvalumab at specified timepoints.
Measured: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Number of participants with adverse events (AEs)
To assess the safety and tolerability of SC durvalumab.
Measured: Up to Survival Follow-up (approximately 17 months)
Number of participants with dose-limiting toxicities (DLTs)
To assess the safety and tolerability of SC durvalumab.
Measured: Up to Survival Follow-up (approximately 17 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start31 Mar 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391670
- Sponsor's protocol ID
- D907HC00001
- Other IDs
- 2025-521639-34-00, 2025
- Acronym
- IMFINZI-subQ
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07391670
- Acronym / sponsor ID
- IMFINZI-subQ / D907HC00001
- Conditions
- Solid Tumours
- Keywords
- Pharmacokinetics, Non-small cell lung cancer (Stage III, unresectable), Small cell lung cancer (Limited stage), Hepatocellular carcinoma (Unresectable), Subcutaneous, Human hyaluronidase, Monoclonal antibody, Programmed cell death ligand 1 (PD-L1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a Phase I, multicentre study that will consist of 2 parts -
- Part 1: Dose Escalation
- Part 2: Dose Expansion
Part 1 may include participants with solid tumours - non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or limited-stage small cell lung cancer (LS-SCLC). It will further consist of 2 planned dose levels of SC durvalumab - Dose level 1 (DL1) and Dose level 2 (DL2).
Part 2 will include participants with unresectable HCC. It will be initiated once a dose has been identified based on Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: SC Durvalumab DL1 | Experimental | Drug: SC durvalumab + rHu, Drug: IV durvalumab, Drug: TremelimumabParticipants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. |
| Part 1: SC Durvalumab DL2 | Experimental | Drug: SC durvalumab + rHu, Drug: IV durvalumab, Drug: TremelimumabParticipants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. |
| Part 2: Expansion Cohort, SC Durvalumab Dose Level X | Experimental | Drug: SC durvalumab + rHu, Drug: IV durvalumab, Drug: TremelimumabParticipants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- Locally Advanced Unresectable (Stage III) NSCLC Participants -
Key exclusion criteria (16 listed)
- 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.
- Locally Advanced Unresectable (Stage III) NSCLC Participants -
- Mixed SCLC and NSCLC histology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC durvalumab + rHuDurvalumab + rHu will be administered subcutaneously. | Drug | Part 1: SC Durvalumab DL1, Part 1: SC Durvalumab DL2, Part 2: Expansion Cohort, SC Durvalumab Dose Level X |
| IV durvalumabAlso: MEDI4736Durvalumab will be administered intravenously. | Drug | Part 1: SC Durvalumab DL1, Part 1: SC Durvalumab DL2, Part 2: Expansion Cohort, SC Durvalumab Dose Level X |
| TremelimumabTremelimumab will be administered to participants with unresectable HCC as an IV infusion. | Drug | Part 1: SC Durvalumab DL1, Part 1: SC Durvalumab DL2, Part 2: Expansion Cohort, SC Durvalumab Dose Level X |
Primary outcome
Area under the concentration-time curve
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
To characterise the AUC of SC durvalumab.
Observed lowest concentration before the next dose is administered (Ctrough)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
To characterise the Ctrough of SC durvalumab
10 secondary outcomes
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Maximum observed concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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])
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Apparent volume of distribution based on the terminal phase volume (Vz[/F])
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Average drug concentration over a dosing interval (Cavg)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Serum concentration of durvalumab
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Number of participants with adverse events (AEs)
Time frame: Up to Survival Follow-up (approximately 17 months)
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to Survival Follow-up (approximately 17 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Thank You Card v1.0 Master FileLink provided by the sponsor.
- Thank You Card v1.0 EN\_AULink provided by the sponsor.
- Thank You Card v1.0 KA\_GELink provided by the sponsor.
- Thank You Card v1.0 KO\_KRLink provided by the sponsor.
- Thank You Card v1.0 PL\_PLLink provided by the sponsor.
- Thank You Card v1.0 ZH\_TWLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC durvalumab + rHu, IV durvalumab and Tremelimumab in people with Solid Tumours, run by AstraZeneca at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Poland, South Korea, Taiwan, Australia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve (time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.