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

Korábbi kezelés

• 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 -

Más betegség

• 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.

Egyéb

• Mixed SCLC and NSCLC histology.
• Mixed SCLC and NSCLC histology.
• Hepatic encephalopathy.
• Uncontrolled ascites.

• 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.