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Clinical Trials List

Protocol NumberD907HC00001
NCT Number(ClinicalTrials.gov Identfier)NCT07391670
Active

2026-03-20 - 2028-01-27

Phase I

Not yet recruiting4

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

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 (IMFINZI-subQ)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    PAREXEL INTERNATIONAL CO., LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/11

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林建良 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Ying Liu
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non-Small Cell Lung Cancer (NSCLC)

Objectives

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).

Test Drug

Imfinzi
Imjudo
Subcutaneous Durvalumab rHu (AZD4773)

Active Ingredient

Durvalumab (MEDI4736)
Tremelimumab (MEDI1123)
Durvalumab and Berahyaluronidase Alfa co-formulation

Dosage Form

Injection
Solution for injection
Solution for subcutaneous injection

Dosage

500 mg/vial (50 mg/mL)
25 mg/vial (20 mg/mL)
500 mg/vial (200 mg/mL)

Endpoints

Area under the concentration-time curve To characterise the AUC of SC durvalumab. 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) To characterise the Ctrough of SC durvalumab From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

Inclution 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.

The Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    40 participants

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