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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05471856




Registration number
NCT05471856
Ethics application status
Date submitted
21/07/2022
Date registered
25/07/2022

Titles & IDs
Public title
A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)
Scientific title
Phase Ia, First in Human Open Label Dose Escalation Trial Evaluating Intravenous BI 1703880 in Combination With Intravenous Ezabenlimab for Treatment of Advanced Solid Tumours
Secondary ID [1] 0 0
2022-000298-22
Secondary ID [2] 0 0
1480-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 1703880
Treatment: Drugs - Ezabenlimab

Experimental: BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards) -


Treatment: Drugs: BI 1703880
BI 1703880

Treatment: Drugs: Ezabenlimab
Ezabenlimab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period
Timepoint [1] 0 0
up to 6 weeks
Secondary outcome [1] 0 0
Occurrence of DLTs during the on-treatment period
Timepoint [1] 0 0
up to 804 days
Secondary outcome [2] 0 0
Maximum measured concentration of BI 1703880 in plasma (Cmax)
Timepoint [2] 0 0
up to 804 days
Secondary outcome [3] 0 0
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Timepoint [3] 0 0
up to 804 days

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).
* Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.
* Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.
* Medically fit and willing to undergo all mandatory trial procedures.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values:

* Absolute neutrophil count = 1.5x10^9/L (= 1.5x10^3/µL, = 1500/mm3); platelet count = 100x10^9/L (= 100x10^3/µL, = 100x10^3/mm3), without the use of hematopoietic growth factors within 4 weeks of start of trial medication
* Haemoglobin = 90 g/L (= 9.0 g/dL, = 5.6 mmol/L)
* Estimated glomerular filtration rate (eGFR) =60 ml/min/1.73m^2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
* Aspartate transaminase (AST) and alanine transaminase (ALT) = 3 x ULN if no demonstrable liver metastases, or otherwise = 5 x ULN if transaminase elevation is attributable to liver metastases.
* Total bilirubin = 1.5 x ULN, except for patients with Gilbert's syndrome: total bilirubin = 3.0 x ULN or direct bilirubin = 1.5 x ULN
* partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT) <1.5 x ULN
* Patients =18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
* Signed and dated written ICF in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation, obtained before performing any protocol related procedures that are not part of normal standard of practice care. Note: If a patient declines to participate in the voluntary biobanking component of the trial, he/she will not be excluded from other aspects of the trial.

Further inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
* Prior STING agonist therapy.
* Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
* History of allergy or hypersensitivity to study agent components.
* Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers.
* Persistent toxicity from previous treatments (including immune related Adverse Events (irAEs)) that has not resolved to Grade =1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies.
* Evidence of active, non-treatment related autoimmune disease, except for endocrinopathies.
* History or complication of pneumonitis or interstitial lung disease within the last 12 months, or any prior pneumonitis related to immunotherapy.

Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Other
Other design features
Phase
Phase 1
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
19/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
Japan
State/province [4] 0 0
Chiba, Kashiwa
Country [5] 0 0
Japan
State/province [5] 0 0
Tokyo, Koto-ku
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Valencia
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Oxford
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
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
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency


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/NCT05471856