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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05155332




Registration number
NCT05155332
Ethics application status
Date submitted
10/12/2021
Date registered
13/12/2021
Date last updated
26/11/2024

Titles & IDs
Public title
A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)
Scientific title
Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
2020-003902-30
Secondary ID [2] 0 0
1456-0001
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 1831169
Treatment: Drugs - anti-PD-1 antibody

Experimental: Part 1 (Monotherapy): Arm A -

Experimental: Part 1 (Monotherapy): Arm B -

Experimental: Part 1 (Monotherapy): Arm C -

Experimental: Part 2 (Combination therapy): Arm D -

Experimental: Part 2 (Combination therapy): Arm E -

Experimental: Part 2 (Combination therapy): Arm F -

Experimental: Part 2 (Combination therapy): Arm G -


Treatment: Drugs: BI 1831169
BI 1831169

Treatment: Drugs: anti-PD-1 antibody
anti-PD-1 antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
Timepoint [1] 0 0
up to 21 days
Primary outcome [2] 0 0
Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
Timepoint [2] 0 0
up to 49 months
Primary outcome [3] 0 0
Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
Timepoint [3] 0 0
up to 21 days
Primary outcome [4] 0 0
Part 2.2, Dose Expansion, Arm D: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
Timepoint [4] 0 0
up to 49 months
Primary outcome [5] 0 0
Part 2.2, Dose Expansion, Arm E, Arm F, Arm G: Objective response (OR) defined as best overall response (BOR) of confirmed intravenous immunotherapy complete response (iCR) or confirmed intravenous immunotherapy partial response (iPR)
Timepoint [5] 0 0
up to 49 months
Secondary outcome [1] 0 0
Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period
Timepoint [1] 0 0
up to 49 months
Secondary outcome [2] 0 0
Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period
Timepoint [2] 0 0
up to 49 months
Secondary outcome [3] 0 0
Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period
Timepoint [3] 0 0
up to 49 months
Secondary outcome [4] 0 0
Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period
Timepoint [4] 0 0
up to 49 months
Secondary outcome [5] 0 0
Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period
Timepoint [5] 0 0
up to 49 months
Secondary outcome [6] 0 0
Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period
Timepoint [6] 0 0
up to 49 months
Secondary outcome [7] 0 0
Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period
Timepoint [7] 0 0
up to 49 months
Secondary outcome [8] 0 0
Part 2.2 - Dose Expansion by Indication, Arm D: Duration of objective response (DoR)
Timepoint [8] 0 0
up to 49 months
Secondary outcome [9] 0 0
Part 2.2, Dose Expansion by Indication, Arm D: Disease control (DC)
Timepoint [9] 0 0
up to 49 months
Secondary outcome [10] 0 0
Part 2.2, Dose Expansion by Indication, Arms E, F, G: Duration of objective response (DoR)
Timepoint [10] 0 0
up to 49 months
Secondary outcome [11] 0 0
Part 2.2, Dose Expansion by Indication, Arms E, F, G: Disease control (DC)
Timepoint [11] 0 0
up to 49 months
Secondary outcome [12] 0 0
Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months
Timepoint [12] 0 0
up to 4 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of an advanced, metastatic or relapsed/refractory solid tumor
* At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., imaging guided procedures) for both biopsies and injections of BI 1831169
* Has failed conventional treatment, or for whom no therapy of proven efficacy exists, or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2 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
* Previous treatment with Vesicular stomatitis virus (VSV)-based agents
* Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
* Use of interferon, immunotherapy agents during the treatment phase, or tamoxifen within 30 days prior to or during treatment phase
* Presence of brain metastases
* Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
* Chronic steroid use, regardless of daily dose Further or exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
28/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/05/2028
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment hospital [2] 0 0
Peninsula Haematology & Oncology - Frankston
Recruitment postcode(s) [1] 0 0
5062 - Bedford Park
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Villejuif
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Tübingen
Country [17] 0 0
Germany
State/province [17] 0 0
Ulm
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
L'Hospitalet de Llobregat
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Pamplona
Country [22] 0 0
Switzerland
State/province [22] 0 0
Bern
Country [23] 0 0
Switzerland
State/province [23] 0 0
Geneve

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.

This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.

Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.
Trial website
https://clinicaltrials.gov/study/NCT05155332
Trial related presentations / publications
Porosnicu M, Quinson AM, Crossley K, Luecke S, Lauer UM. Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid tumors. Future Oncol. 2022 Aug;18(24):2627-2638. doi: 10.2217/fon-2022-0439. Epub 2022 Jun 14.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05155332