Under construction – not a live service
Sign in
Taking people in TaiwanPhase 1

Durvalumab given under the skin in adults with solid tumours

Tests durvalumab injected under the skin in adults with solid tumours.

Key facts

Who runs it
AstraZeneca
Where
Tainan, Taipei, and Taoyuan, TaiwanSee the 3 sitesAlso in 4 other countries, 12 sites
Registry title
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Status
Recruiting
Phase
Phase 1
People taking part
40 people, planned
Started
31 Mar 2026
Expected to end
30 Aug 2027
Type of study
Interventional, 3 groups
Treatments tested
  • SC durvalumab + rHu
  • IV durvalumab
  • Tremelimumab
Record updated
24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain solid tumours: stage III lung cancer that cannot be removed by surgery, limited-stage small cell lung cancer, or liver cancer that cannot be removed by surgery. It tests durvalumab given under the skin.

Age
18 years or older
Sex
All sexes can join
Disease stage
Lung cancer (non-small cell) stage III that cannot be removed by surgery; small cell lung cancer, limited stage (stage I-III); liver cancer (hepatocellular carcinoma) that cannot be removed by surgery, Child-Pugh class A, with measurable disease
Earlier treatment
Lung cancer groups: at least 2 cycles of platinum-based chemotherapy together with definitive radiation therapy (4 cycles of chemotherapy with radiotherapy for small cell lung cancer), and no progression afterwards. Liver cancer: no earlier systemic therapy. No earlier immune checkpoint inhibitors.

Main reasons for not taking part

  • Autoimmune disease that needed or needs treatment with the whole body
  • Uncontrolled infection, including HIV, hepatitis B or C
  • Earlier treatment with immune checkpoint inhibitors
  • Mixed small cell and non-small cell lung cancer; active pneumonitis or interstitial lung disease needing systemic therapy
  • Liver cancer: hepatic encephalopathy, uncontrolled ascites, or active gastrointestinal bleeding

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active or prior documented autoimmune disease requiring systemic treatment
  • Prior exposure to immune checkpoint inhibitors; Part 1 only:; Locally Advanced Unresectable (Stage III) NSCLC Participants -
  • Uncontrolled infection (including human immunodeficiency virus [HIV], hepatitis B or C)
  • Active pneumonitis or interstitial lung disease requiring systemic therapy; LS SCLC Participants -
  • Extensive-stage disease
  • History of Grade ≥ 2 pneumonitis; Part 1 and 2:; Unresectable HCC Participants -
  • Active gastrointestinal (GI) bleeding
  • Mixed SCLC and NSCLC histology
  • Mixed SCLC and NSCLC histology
  • Hepatic encephalopathy
  • Uncontrolled ascites

Where in Taiwan

Also in 4 other countries, 12 sites

  • TainanHospital not named in the registryTaking people
  • TaipeiHospital not named in the registryTaking people
  • TaoyuanHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Part 1: SC Durvalumab DL1Treatment being tested

    Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.

    Treatment: SC durvalumab + rHu, IV durvalumab, and Tremelimumab

  • Part 1: SC Durvalumab DL2Treatment being tested

    Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.

    Treatment: SC durvalumab + rHu, IV durvalumab, and Tremelimumab

  • Part 2: Expansion Cohort, SC Durvalumab Dose Level XTreatment being tested

    Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.

    Treatment: SC durvalumab + rHu, IV durvalumab, and Tremelimumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Durvalumab given under the skin in adults with solid tumoursGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
24 September 2026