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Subcutaneous durvalumab plus hyaluronidase dose-finding and safety for solid tumors

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

PHASE1 · AstraZeneca · NCT07391670

This study will test whether a subcutaneous (under-the-skin) injection of durvalumab with hyaluronidase gives similar blood levels and is safe for people with certain advanced solid tumors, including unresectable liver cancer and specific forms of lung cancer.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionschemotherapy, radiation, durvalumab
Locations19 sites (Fitzroy and 18 other locations)
Trial IDNCT07391670 on ClinicalTrials.gov

What this trial studies

This Phase I, multicenter study uses a two-part design with a dose-escalation stage followed by a dose-expansion stage. In Part 1 participants with selected solid tumors (including stage III unresectable NSCLC, limited-stage SCLC, or unresectable HCC) will receive planned subcutaneous durvalumab doses (DL1 and DL2) with recombinant human hyaluronidase to identify a dose that matches IV exposure, with pharmacokinetics and safety closely monitored. Part 2 will expand at the selected dose in participants with unresectable hepatocellular carcinoma to further characterize PK and tolerability. The protocol includes comparisons to standard intravenous durvalumab and allows exploration of combinations such as tremelimumab where specified.

Who should consider this trial

Good fit: Adults with certain advanced solid tumors who meet safety criteria (ECOG 0–1, adequate organ function, minimum weight >30 kg) and the tumor-specific entry requirements are eligible.

Not a fit: Patients who do not meet the organ function, weight, or performance-status criteria, or who have disease that progressed outside the study’s allowable windows, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, a subcutaneous formulation could shorten clinic visits and make durvalumab dosing easier while maintaining similar drug exposure to the intravenous form.

How similar studies have performed: Other therapeutic antibodies have been successfully reformulated as subcutaneous injections with hyaluronidase showing comparable exposure and acceptable safety in early-phase work, though subcutaneous durvalumab is a newer application of this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 -

* 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.

Exclusion Criteria:

* 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.
* Active gastrointestinal (GI) bleeding.

Where this trial is running

Fitzroy and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumours, Pharmacokinetics, Non-small cell lung cancer, Small cell lung cancer, Hepatocellular carcinoma, Subcutaneous, Human hyaluronidase, Monoclonal antibody

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.