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

2025-521639-34-00 Protocol D907HC00001 Human pharmacology (Phase I) - Other Authorised, recruiting

Start 20 Apr 2026 · Status Authorised, recruiting · 1 EU/EEA countries · 5 sites · Protocol D907HC00001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruiting
Participants planned 40
Countries 1
Sites 5

• 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

To characterise the PK profile of SC durvalumab.

Key facts

Sponsor
AstraZeneca AB
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
20 Apr 2026 → ongoing
Decision date (initial)
2026-03-27
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy, Pharmacokinetic, Others

To characterise the PK profile of SC durvalumab.

Secondary objectives 2

  1. To further characterize the PK profile of SC durvalumab.
  2. To assess the safety and tolerability of SC durvalumab.

Conditions and MedDRA coding

• 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

VersionLevelCodeTermSystem organ class
27.1 PT 10061873 Non-small cell lung cancer 100000004864
21.1 PT 10041067 Small cell lung cancer 100000004864
20.0 PT 10073071 Hepatocellular carcinoma 100000004864

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Food And Drug Administration
Plan to share IPD
Yes
IPD plan description
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. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Participant ≥18 years at time of consent.
  2. ECOG performance status 0 - 1.
  3. Adequate organ and marrow function at enrolment as defined in the protocol.
  4. Histologically or cytologically confirmed.
  5. Locally advanced unresectable Stage III NSCLC (post-definitive chemoradiation, no progression).
  6. Unresectable hepatocellular carcinoma (BCLC stage B or C, Child-Pugh A, no prior systemic therapy).
  7. Limited-stage small cell lung cancer (post-definitive chemoradiation, no progression).
  8. Advanced or metastatic NSCLC (EGFR/ALK wild-type, prior anti-PD-(L)1 and platinum-based therapy).

Exclusion criteria 7

  1. Active autoimmune disease requiring systemic treatment.
  2. Uncontrolled infection (including HIV, hepatitis B or C).
  3. Symptomatic brain metastases not controlled by treatment.
  4. Prior exposure to immune checkpoint inhibitors (except for advanced/metastatic NSCLC cohort).
  5. HCC: Hepatic encephalopathy, uncontrolled ascites, active gastrointestinal bleeding.
  6. NSCLC: Active pneumonitis or interstitial lung disease requiring systemic therapy.
  7. LS-SCLC: Extensive-stage disease, uncontrolled CNS metastases.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. AUC and Ctrough

Secondary endpoints 2

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Ceralasertib

PRD10810116 · Product

Active substance
Ceralasertib
Substance synonyms
AZD-6738, 4-(4-(1-((S(R))-S-METHYLSULFONIMIDOYL)CYCLOPROPYL)-6-((3R)-3-METHYL-4-MORPHOLINYL)-2-PYRIMIDINYL)-1H-PYRROLO(2,3-B)PYRIDINE, AZD6738
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
99999 Day(s)
Authorisation status
Not Authorised
MA holder
ASTRAZENECA AB
Paediatric formulation
No
Orphan designation
No

IMFINZI 50 mg/mL concentrate for solution for infusion

PRD6651398 · Product

Active substance
Durvalumab
Substance synonyms
MEDI4736
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1500 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
99999 Day(s)
Authorisation status
Authorised
ATC code
L01FF03 — -
Marketing authorisation
EU/1/18/1322/001
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Repackaging and relabeling

Ceralasertib

PRD10419091 · Product

Active substance
Ceralasertib
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
9999 Day(s)
Authorisation status
Not Authorised
MA holder
ASTRAZENECA AB
Paediatric formulation
No
Orphan designation
No

AZD4773

PRD12689550 · Product

Active substance
Durvalumab
Substance synonyms
MEDI4736
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
99999 Day(s)
Authorisation status
Not Authorised
MA holder
ASTRAZENECA AB
Paediatric formulation
No
Orphan designation
No

IMJUDO 20 mg/ml concentrate for solution for infusion.

PRD10239823 · Product

Active substance
Tremelimumab
Substance synonyms
CP-675,206, Ticilimumab, MEDI1123
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
300 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01FX20 — -
Marketing authorisation
EU/1/22/1713/002
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Repackaging and relabeling

Auxiliary 2

Infliximab

SUB02681MIG · Substance

Active substance
Infliximab
Pharmaceutical form
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
5 mg/kg milligram(s)/kilogram
Max total dose
00 mg/kg milligram(s)/kilogram
Max treatment duration
99999 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Repackaging and labeling

Mycophenolate Mofetil

SUB03360MIG · Substance

Active substance
Mycophenolate Mofetil
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
3 g gram(s)
Max total dose
00 g gram(s)
Max treatment duration
99999 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Repackaging and relabeling

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

274 Total trials 84 Recruiting 173 Ended
Commercial
Sponsor organisation
AstraZeneca AB
Address
-
City
Sodertalje
Postcode
151 85
Country
Sweden

Scientific contact point

Organisation
AstraZeneca AB
Contact name
AstraZeneca Clinical Study Information Center

Public contact point

Organisation
AstraZeneca AB
Contact name
AstraZeneca Clinical Study Information Center

Third parties 1

OrganisationCity, countryDuties
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Other, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, E-data capture, Code 8, Code 9

Locations

1 EU/EEA country · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Authorised, recruiting 4 5
Rest of world
Australia, Taiwan, Georgia, Korea, Republic of
 — 36 —

Investigational sites

Poland

5 sites · Authorised, recruiting
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
5703: I Oddzial Onkologii Klinicznej z Chemioterapią Dzienną, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
5704: Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
5701: Oddzial Onkologiczny z Pododdziałem Dziennej Chemioterapii, Ul. Monte Cassino 18, 37-700, Przemysl
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
5705: Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
5702: Oddział Dzienny Chemioterapii i Hematologii Onkologicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Poland 2026-04-20

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol Main English D907HC00001 Public 1.0
Recruitment arrangements (for publication) K1_POL Recruitment Procedure Description PL-EN D907HC00001 Public 1.0
Subject information and informed consent form (for publication) L1_POL Country ICF - Pregnant Form Polish D907HC00001 Public 1.0
Subject information and informed consent form (for publication) L1_POL Country ICF Main Polish D907HC00001 Public 1.2
Summary of Product Characteristics (SmPC) (for publication) E2_Marketed Product Material Durvalumab IV D907HC00001 Public NA
Summary of Product Characteristics (SmPC) (for publication) E2_Marketed Product Material Tremelimumab D907HC00001 Public NA
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main English D907HC00001 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Polish D907HC00001 Public 1.0

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-11-19 Poland Acceptable
2026-03-23
 2026-03-27