Health Trials

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

ConditionSolid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Mixed SCLC and NSCLC histology.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SC durvalumab + rHu

    Drug

    Durvalumab + rHu will be administered subcutaneously.

  • IV durvalumab

    Drug

    Durvalumab will be administered intravenously.

  • Tremelimumab

    Drug

    Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Part 1: SC Durvalumab DL1Experimental treatment 3 interventions
Group B: Part 1: SC Durvalumab DL2Experimental treatment 3 interventions
Group C: Part 2: Expansion Cohort, SC Durvalumab Dose Level XExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Area under the concentration-time curve

To characterise the AUC of SC durvalumab.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
2

Observed lowest concentration before the next dose is administered (Ctrough)

To characterise the Ctrough of SC durvalumab

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

Secondary outcomes

1

Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)

To characterise the AUClast of SC durvalumab.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
2

Maximum observed concentration (Cmax)

To characterise the Cmax of SC durvalumab.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
3

Time to reach maximum concentration following drug administration (tmax)

To characterise the tmax of SC durvalumab.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
4

Terminal elimination half-life (t1/2λz)

To characterise the t1/2λz of SC durvalumab.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

Other outcomes

Sponsors and contacts

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AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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