Trials / Recruiting
RecruitingNCT07391670
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-03-31
- Primary completion
- 2027-08-30
- Completion
- 2027-08-30
- First posted
- 2026-02-06
- Last updated
- 2026-04-17
Locations
19 sites across 5 countries: Australia, Georgia, Poland, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07391670. Inclusion in this directory is not an endorsement.