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)

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521639-34-00

Enrollment

Registered

2026-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• Non-small cell lung cancer (Stage III, unresectable) • Small cell lung cancer (Limited stage) • Hepatocellular carcinoma (Unresectable) • Advanced or Metastatic non-small cell lung cancer

Brief summary

AUC and Ctrough

Detailed description

Other PK parameters (including Ctrough, AUClast, Cmax, tmax, t1/2λz, CL(/F),Vz(/F), and Cavg) and serum durvalumab concentrations at specified timepoints., DLT assessment, AEs (including SC site of administration-related AEs), physical examination, clinical laboratory assessments, vital signs, and ECOG performance status.

Interventions

DRUGCeralasertib

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion

DRUGINFLIXIMAB

DRUGMYCOPHENOLATE MOFETIL

DRUGAZD4773

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AUC and Ctrough	—

Secondary

Measure	Time frame
Other PK parameters (including Ctrough, AUClast, Cmax, tmax, t1/2λz, CL(/F),Vz(/F), and Cavg) and serum durvalumab concentrations at specified timepoints., DLT assessment, AEs (including SC site of administration-related AEs), physical examination, clinical laboratory assessments, vital signs, and ECOG performance status.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 28, 2026