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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Batumi, Georgia Recruiting
• Research Site
  Tbilisi, Georgia Recruiting
• Research Site
  Tbilisi, Georgia Recruiting
• Research Site
  Brzozów, Poland Recruiting
• Research Site
  Koszalin, Poland Recruiting
• Research Site
  Lublin, Poland Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.