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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06219941




Registration number
NCT06219941
Ethics application status
Date submitted
21/11/2023
Date registered
23/01/2024

Titles & IDs
Public title
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Scientific title
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2.
Secondary ID [1] 0 0
D9800C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Cancer 0 0
Pancreatic Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD0901
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - l-leucovorin
Treatment: Drugs - Irinotecan
Treatment: Drugs - Nanoliposomal Irinotecan
Treatment: Drugs - Gemcitabine

Experimental: Sub Study 1 - AZD0901 MONOTHERAPY - Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.

Experimental: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS - Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents


Treatment: Drugs: AZD0901
Antibody-drug conjugate/Biologic

Treatment: Drugs: 5-Fluorouracil
Chemotherapy agents

Treatment: Drugs: Leucovorin
Chemotherapy agents

Treatment: Drugs: l-leucovorin
Chemotherapy agents

Treatment: Drugs: Irinotecan
Chemotherapy agents

Treatment: Drugs: Nanoliposomal Irinotecan
Chemotherapy agents

Treatment: Drugs: Gemcitabine
Chemotherapy agents
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs.
Timepoint [1] 0 0
30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
Primary outcome [2] 0 0
Objective Response Rate (ORR).
Timepoint [2] 0 0
From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
From the date of first documented confirmed response until date of documented progression (approximately 2 years).
Secondary outcome [4] 0 0
Disease control rate (DCR)
Timepoint [4] 0 0
From start until 12 weeks.
Secondary outcome [5] 0 0
Percentage change in tumor size
Timepoint [5] 0 0
From start through to study completion.
Secondary outcome [6] 0 0
Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE
Timepoint [6] 0 0
From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.
Secondary outcome [7] 0 0
Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.
Timepoint [7] 0 0
From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.
Secondary outcome [8] 0 0
Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance.
Timepoint [8] 0 0
From date of first dose of AZD0901 up to 7 weeks.
Secondary outcome [9] 0 0
ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.
Timepoint [9] 0 0
From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

Eligibility
Key inclusion criteria
Master Inclusion Criteria applicable to both sub studies:

* Participant must be = 18 years or the legal age of consent at the time of signing the ICF.
* Participants who are CLDN18.2 positive.
* Must have at least one measurable lesion according to RECIST v1.1.
* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
* Predicted life expectancy of = 12 weeks.
* Adequate organ and bone marrow function as defined by protocol.
* Body weight > 35 kg.
* Participants are willing to comply with contraception requirements.

Sub study 1 Specific Inclusion criteria:

* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
* Advanced or metastatic GC/GEJC.
* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.

Sub study 2 Specific Inclusion criteria:

* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
* Availability of an archival sample or a fresh tumour biopsy taken at screening.
* No prior treatments for unresectable or metastatic disease.

Master
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria applicable to both sub studies:

* Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
* Participants with clinically significant ascites that require drainage.
* A history of drug-induced non-infectious ILD/pneumonitis.
* Central nervous system metastases or CNS pathology.
* Peripheral neuropathy = Grade 2 at screening.
* History of another primary malignancy.
* Prior exposure to any MMAE-based ADC.
* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.

Sub study 1 Specific Exclusion criteria:

* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
* The use of concomitant medications known to prolong the QT/QTc interval.

Sub study 2 Specific Exclusion criteria:

* Known DPD enzyme deficiency based on local testing where testing is SoC.
* Use of strong inhibitor or inducer of UGT1A1.
* Use of strong inhibitors or inducers of CYP3A4.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/01/2027
Actual
Sample size
Target
123
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment hospital [2] 0 0
Research Site - Murdoch
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
WA6150 - Murdoch
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Georgia
State/province [8] 0 0
Tbilisi
Country [9] 0 0
Japan
State/province [9] 0 0
Chuo-ku
Country [10] 0 0
Japan
State/province [10] 0 0
Kashiwa
Country [11] 0 0
Japan
State/province [11] 0 0
Kitaadachi-gun
Country [12] 0 0
Japan
State/province [12] 0 0
Koto-ku
Country [13] 0 0
Japan
State/province [13] 0 0
Nagoya-shi
Country [14] 0 0
Japan
State/province [14] 0 0
Osakasayama-shi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Malaysia
State/province [16] 0 0
George Town
Country [17] 0 0
Malaysia
State/province [17] 0 0
Johor Bahru
Country [18] 0 0
Malaysia
State/province [18] 0 0
Kuala Lumpur
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kuching
Country [20] 0 0
Malaysia
State/province [20] 0 0
Selangor
Country [21] 0 0
Moldova, Republic of
State/province [21] 0 0
Chisinau
Country [22] 0 0
Poland
State/province [22] 0 0
Kraków
Country [23] 0 0
Poland
State/province [23] 0 0
Warszawa
Country [24] 0 0
Singapore
State/province [24] 0 0
Bukit Merah
Country [25] 0 0
Singapore
State/province [25] 0 0
Singapore
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Taiwan
State/province [28] 0 0
Kaohsiung
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taichung
Country [30] 0 0
Taiwan
State/province [30] 0 0
Tainan City
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei City
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taoyuan
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Glasgow
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Leeds
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06219941