Clinical trial • Phase I • Oncology

CERALASERTIB for Non-small cell lung cancer | Small cell lung cancer | Hepatocellular carcinoma | Metastatic non-small cell lung cancer

Phase I trial of CERALASERTIB for Non-small cell lung cancer | Small cell lung cancer | Hepatocellular carcinoma | Metastatic non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Small cell lung cancer | Hepatocellular carcinoma | Metastatic non-small cell lung cancer
Trial Stage
Phase I
Drug Modality
Small molecule | Monoclonal antibody | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
19-11-2025
First CTIS Authorization Date
27-03-2026

Trial design

None/Not specified-controlled, adaptive Phase I trial in Poland.

Comparator
None/Not specified
Adaptive
True, Dose escalation and dose expansion design (dose-escalation cohorts and dose-expansion cohort). No specific escalation rules, interim analyses or stopping rules are provided in the available documents.
Biomarker Stratified
True, EGFR/ALK wild-type
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
36

Eligibility

Recruits 36 Vulnerable population is selected in the trial metadata. Participants must be ≥18 years at time of consent. No further details on consent or assent handling for vulnerable participants are provided in the available documents..

Vulnerable Population
Vulnerable population is selected in the trial metadata. Participants must be ≥18 years at time of consent. No further details on consent or assent handling for vulnerable participants are provided in the available documents.

Inclusion criteria

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

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- AUC and Ctrough","definition_or_measurement_approach":"Pharmacokinetic measures: area under the concentration–time curve (AUC) and trough concentration (Ctrough)."}

Secondary endpoints

  • {"endpoint_text":"- Other PK parameters (including Ctrough, AUClast, Cmax, tmax, t1/2λz, CL(/F),Vz(/F), and Cavg) and serum durvalumab concentrations at specified timepoints.","definition_or_measurement_approach":"Measurement of PK parameters (Ctrough, AUClast, Cmax, tmax, t1/2λz, CL(/F), Vz(/F), Cavg) and serum durvalumab concentrations at specified timepoints."}
  • {"endpoint_text":"- DLT assessment, AEs (including SC site of administration-related AEs), physical examination, clinical laboratory assessments, vital signs, and ECOG performance status.","definition_or_measurement_approach":"Safety and tolerability assessments including dose-limiting toxicity (DLT) assessment, adverse event (AE) recording (including SC administration site AEs), physical exams, clinical labs, vital signs and ECOG performance status evaluations."}

Recruitment

Planned Sample Size
36
Recruitment Window Months
26
Consent Approach
Informed consent provided by the participant (Participant ≥18 years at time of consent). Country-specific ICF documents available in Polish (L1_POL Country ICF Main Polish; L1_POL Country ICF - Pregnant Form Polish). No further details on assent or additional languages provided in the available documents.

Geography

Total Number Of Sites
5
Total Number Of Participants
36

Poland

Earliest CTIS Part Ii Submission Date
11-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
16
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
5701: Oddzial Onkologiczny z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
5702: Oddział Dzienny Chemioterapii i Hematologii Onkologicznej
Contact Person Name
Joanna Kiszka
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
5704: Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
5705: Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
JarosIaw KoIb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
5703: I Oddzial Onkologii Klinicznej z Chemioterapią Dzienną
Contact Person Name
Agata Chrzanowska-Kapica
Contact Person Email
achrzanowska@cozl.eu

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Logistic management; additional sponsor duties referenced by code in CTIS record

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Logistic management; other sponsor duties referenced by code in CTIS record","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ceralasertib
Active Substance
CERALASERTIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Authorised (marketing authorisation number: EU/1/18/1322/001)
Maximum Dose
1500 mg
Investigational Product Name
AZD4773
Active Substance
DURVALUMAB, HYALURONIDASE (HUMAN RECOMBINANT)
Modality
Monoclonal antibody | Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Investigational Product Name
IMJUDO 20 mg/ml concentrate for solution for infusion.
Active Substance
TREMELIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Authorised (marketing authorisation number: EU/1/22/1713/002)
Maximum Dose
300 mg
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Maximum Dose
5 mg/kg
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
3 g

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