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A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab

NCT07391670

RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Solid Tumours

Interventions: SC durvalumab + rHu, IV durvalumab, Tremelimumab

Countries: Australia, Georgia, Poland, South Korea, Taiwan

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (19)
  • Fitzroy, Australia
  • St Albans, Australia
  • Woolloongabba, Australia
  • Batumi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Brzozów, Poland
  • Koszalin, Poland
  • Lublin, Poland
  • Olsztyn, Poland
  • Przemyśl, Poland
  • Seongnam-si, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan