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En fas I-studie för doseskalering och dosexpansion för att undersöka farmakokinetiken och säkerheten för subkutan Durvalumab (IMFINZI-subQ)

23 september 2026 uppdaterad av: AstraZeneca

En fas I, multicentrisk, doseskalerings- och dosexpansionsstudie för att undersöka farmakokinetiken och säkerheten av subkutan Durvalumab hos vuxna deltagare med solida tumörer

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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Australien
      • Fitzroy, Australien, 3065
        • Indragen
        • Research Site
      • St Albans, Australien, 3021
        • Indragen
        • Research Site
      • Woolloongabba, Australien, 4102
        • Indragen
        • Research Site
  • Georgien
      • Batumi, Georgien, 6010
        • Rekrytering
        • Research Site
      • Tbilisi, Georgien, 0114
        • Rekrytering
        • Research Site
      • Tbilisi, Georgien, 0112
        • Rekrytering
        • Research Site
  • Polen
      • Brzozów, Polen, 36-200
        • Rekrytering
        • Research Site
      • Koszalin, Polen, 75-581
        • Rekrytering
        • Research Site
      • Lublin, Polen, 20-090
        • Rekrytering
        • Research Site
      • Olsztyn, Polen, 10-357
        • Rekrytering
        • Research Site
      • Przemyśl, Polen, 37-700
        • Rekrytering
        • Research Site
  • Sydkorea
      • Seongnam-si, Sydkorea, 13620
        • Rekrytering
        • Research Site
      • Seoul, Sydkorea, 06351
        • Rekrytering
        • Research Site
      • Seoul, Sydkorea, 5505
        • Rekrytering
        • Research Site
      • Seoul, Sydkorea, 03722
        • Rekrytering
        • Research Site
  • Taiwan
      • Tainan, Taiwan, 73657
        • Rekrytering
        • Research Site
      • Taipei, Taiwan, 112
        • Indragen
        • Research Site
      • Taipei, Taiwan, 110
        • Rekrytering
        • Research Site
      • Taoyuan, Taiwan, 333
        • Indragen
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part 1: SC Durvalumab DL1

Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Läkemedel: SC durvalumab + rHu

Durvalumab + rHu will be administered subcutaneously.

Läkemedel: IV durvalumab

Durvalumab will be administered intravenously.

Andra namn:
  • MEDI4736
Läkemedel: Tremelimumab

Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.
Experimentell: Part 1: SC Durvalumab DL2

Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Läkemedel: SC durvalumab + rHu

Durvalumab + rHu will be administered subcutaneously.

Läkemedel: IV durvalumab

Durvalumab will be administered intravenously.

Andra namn:
  • MEDI4736
Läkemedel: Tremelimumab

Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.
Experimentell: Part 2: Expansion Cohort, SC Durvalumab Dose Level X

Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Läkemedel: SC durvalumab + rHu

Durvalumab + rHu will be administered subcutaneously.

Läkemedel: IV durvalumab

Durvalumab will be administered intravenously.

Andra namn:
  • MEDI4736
Läkemedel: Tremelimumab

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Area under the concentration-time curve
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

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

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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the AUClast of SC durvalumab.
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Maximum observed concentration (Cmax)
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the Cmax of SC durvalumab.
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)
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the tmax of SC durvalumab.
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)
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the t1/2λz of SC durvalumab.
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])
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the CL(/F) of SC durvalumab.
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])
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the VZ(/F) of SC durvalumab.
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)
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the Cavg of SC durvalumab.
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Serum concentration of durvalumab
Tidsram: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).

To characterise the serum concentration of SC durvalumab at specified timepoints.
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)
Tidsram: Up to Survival Follow-up (approximately 17 months)

To assess the safety and tolerability of SC durvalumab.
Up to Survival Follow-up (approximately 17 months)
Number of participants with dose-limiting toxicities (DLTs)
Tidsram: Up to Survival Follow-up (approximately 17 months)

To assess the safety and tolerability of SC durvalumab.
Up to Survival Follow-up (approximately 17 months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 mars 2026

Primärt slutförande (Beräknad)

30 augusti 2027

Avslutad studie (Beräknad)

30 augusti 2027

Studieregistreringsdatum

Först inskickad

30 januari 2026

Först inskickad som uppfyllde QC-kriterierna

30 januari 2026

Första postat (Faktisk)

6 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D907HC00001
  • 2025-521639-34-00 (Annan identifierare: EU CT number)
  • 2025 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Tidsram för IPD-delning

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kriterier för IPD Sharing Access

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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