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Recruiting NCT07391670

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

Phase I Interventional Solid Tumours

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SC durvalumab + rHu, IV durvalumab, Tremelimumab.
Who it may be relevant to
Registry conditions: Solid Tumours. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Georgia, Poland, South Korea, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Detailed description

This is a Phase I, multicentre study that will consist of 2 parts -

* Part 1: Dose Escalation * Part 2: Dose Expansion

Part 1 may include participants with solid tumours - non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or limited-stage small cell lung cancer (LS-SCLC). It will further consist of 2 planned dose levels of SC durvalumab - Dose level 1 (DL1) and Dose level 2 (DL2).

Part 2 will include participants with unresectable HCC. It will be initiated once a dose has been identified based on Part 1.

Interventions

  • Drug SC durvalumab + rHu
    Durvalumab + rHu will be administered subcutaneously.
  • Drug IV durvalumab
    Durvalumab will be administered intravenously.
  • Drug Tremelimumab
    Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.

Primary outcome measures

  • Area under the concentration-time curve [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Observed lowest concentration before the next dose is administered (Ctrough) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
Secondary outcome measures (10)
  • Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Maximum observed concentration (Cmax) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Time to reach maximum concentration following drug administration (tmax) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Terminal elimination half-life (t1/2λz) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Total body clearance/apparent total body clearance (CL[/F]) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Apparent volume of distribution based on the terminal phase volume (Vz[/F]) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Average drug concentration over a dosing interval (Cavg) [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Serum concentration of durvalumab [Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).]
  • Number of participants with adverse events (AEs) [Time frame: Up to Survival Follow-up (approximately 17 months)]
  • Number of participants with dose-limiting toxicities (DLTs) [Time frame: Up to Survival Follow-up (approximately 17 months)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 5 centers
  • Research Site — Brzozów
  • Research Site — Koszalin
  • Research Site — Lublin
  • Research Site — Olsztyn
  • Research Site — Przemyśl
South Korea · 4 centers
  • Research Site — Seongnam-si
  • Research Site — Seoul
  • Research Site — Seoul
  • Research Site — Seoul
Taiwan · 4 centers
  • Research Site — Tainan
  • Research Site — Taipei
  • Research Site — Taipei
  • Research Site — Taoyuan
Australia · 3 centers
  • Research Site — Fitzroy
  • Research Site — St Albans
  • Research Site — Woolloongabba
Georgia · 3 centers
  • Research Site — Batumi
  • Research Site — Tbilisi
  • Research Site — Tbilisi

Identifiers

NCT: NCT07391670 · D907HC00001 · 2025-521639-34-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗