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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04958239




Registration number
NCT04958239
Ethics application status
Date submitted
1/07/2021
Date registered
12/07/2021

Titles & IDs
Public title
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
Scientific title
An Open Label, Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers, and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Secondary ID [1] 0 0
2021-000234-34
Secondary ID [2] 0 0
1463-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 765179
Treatment: Drugs - Ezabenlimab
Treatment: Drugs - Pembrolizumab

Experimental: Phase 1 Arm A: BI 765179 -

Experimental: Phase 1a Arm B: BI 765179 + ezabenlimab -

Experimental: Phase 1b Cohort 1: pembrolizumab + low dose of BI 765179 -

Experimental: Phase 1b Cohort 2: pembrolizumab + high dose of BI 765179 -


Treatment: Drugs: BI 765179
BI 765179

Treatment: Drugs: Ezabenlimab
Ezabenlimab

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

Outcomes
Primary outcome [1] 0 0
Phase 1a: Maximum Tolerated Dose (MTD)
Timepoint [1] 0 0
Up to Day 21 (end of Cycle 1)
Primary outcome [2] 0 0
Phase 1a: Occurrence of Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Timepoint [2] 0 0
Up to Day 21 (end of Cycle 1)
Primary outcome [3] 0 0
Phase 1b: Objective response (OR)
Timepoint [3] 0 0
Up to 2 years.
Secondary outcome [1] 0 0
Phase 1a: Occurrence of DLTs during the on-treatment period (per arm)
Timepoint [1] 0 0
up to 36 months
Secondary outcome [2] 0 0
Phase 1a: Maximum measured concentration of BI 765179 in plasma (Cmax)
Timepoint [2] 0 0
Up to Day 21 (end of Cycle 1)
Secondary outcome [3] 0 0
Phase 1a: Area under the concentration-time curve of BI 765179 in plasma over a uniform dosing interval from zero to 504h (AUC0-504)
Timepoint [3] 0 0
Up to Day 21 (end of Cycle 1)
Secondary outcome [4] 0 0
Phase Ib: Occurrence of adverse events (AEs) using the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5
Timepoint [4] 0 0
Up to 2 years.
Secondary outcome [5] 0 0
Phase 1b: Occurrence of serious AEs (SAEs) during the on-treatment period
Timepoint [5] 0 0
Up to 2 years.
Secondary outcome [6] 0 0
Phase 1b: OR assessed by the Investigator according to immune-related RECIST (iRECIST)
Timepoint [6] 0 0
Up to 2 years.
Secondary outcome [7] 0 0
Phase Ib: Duration of response (DoR) assessed by RECIST v1.1
Timepoint [7] 0 0
Up to 2 years.
Secondary outcome [8] 0 0
Phase 1b: DoR assessed by iRECIST
Timepoint [8] 0 0
Up to 2 years.
Secondary outcome [9] 0 0
Phase 1b: Progression-free survival (PFS) in all patients assessed by the Investigator according to RECIST v1.1
Timepoint [9] 0 0
Up to 2 years.
Secondary outcome [10] 0 0
Phase 1b: PFS in all patients assessed by the Investigator according to iRECIST
Timepoint [10] 0 0
Up to 2 years.
Secondary outcome [11] 0 0
Phase 1b: PFS rate at 14 weeks
Timepoint [11] 0 0
Up to 2 years.
Secondary outcome [12] 0 0
Phase 1b: Overall survival (OS)
Timepoint [12] 0 0
Up to 2 years.
Secondary outcome [13] 0 0
Phase 1b: OS rate at 12 months
Timepoint [13] 0 0
Up to 2 years.

Eligibility
Key inclusion criteria
All cohorts:

* Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate
* Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies:

* Non-small cell lung carcinoma (NSCLC)
* Gastric cancer
* Esophageal adenocarcinoma or squamous cell carcinoma
* Urothelial bladder carcinoma
* Head and neck squamous cell carcinoma
* Cutaneous malignant melanoma
* Cutaneous squamous cell carcinoma
* Hepatocellular carcinoma
* Pancreatic adenocarcinoma
* Colorectal cancer
* Malignant pleural mesothelioma
* Cervical squamous cell cancer
* Ovarian carcinoma
* Triple-negative breast cancer
* At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
* Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
* At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response evaluation criteria in solid tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate liver, bone marrow and renal organ function
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of the study medication. A list of contraception methods meeting these criteria is provided in the patient information.
* Patients with brain metastases are eligible provided they meet all of the following criteria:

* Brain metastases have adequately been treated and are considered stable by the Investigator
* Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
* Patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
* The patient is off anti-epileptic drugs for at least 7 days

Back-fill cohorts only:

* Patient has agreed to and signed an IC form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
* At least one lesion (separate from the evaluable target lesion outside of the CNS as defined per RECIST v1.1) that is accessible for mandatory paired pre and on-treatment biopsy

Phase 1b:

* Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent head and neck squamous cell carcinoma (HNSCC)
* No prior systemic therapy administered in the metastatic or incurable, recurrent setting
* Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
* At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
* Signed and dated written IC in accordance with ICH-GCP and local legislation prior to admission to 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
Phase 1a

* Currently enrolled in another investigational device or drug trial
* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:

* Effectively treated non-melanoma skin cancers
* Effectively treated carcinoma in situ of the cervix
* Effectively treated ductal carcinoma in situ
* Other effectively treated malignancy that is considered cured by 'local treatment'
* Previous treatment with agents targeting CD137
* Known leptomeningeal disease or spinal cord compression due to disease
* Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
* Persistent toxicity from previous treatments that has not resolved to = Common terminology criteria for adverse events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy)
* Patient has a diagnosis of immunodeficiency
* Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion:

* Use of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
* Systemic corticosteroids at physiologic doses =10 mg/day (prednisone or equivalent)
* Physiological replacement dose of corticosteroids Further exclusion criteria apply.

Phase Ib

* Disease suitable for local therapy administered with curative intent
* Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology)
* Currently enrolled in another investigational device or drug trial
* Life expectancy of <3 months and/or has rapidly progressing disease
* Diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or in situ breast cancers Further 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
18/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/11/2028
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Border Cancer Hospital - Albury
Recruitment hospital [2] 0 0
Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [3] 0 0
Orange Health Service - Orange
Recruitment hospital [4] 0 0
Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2800 - Orange
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
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
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
South Dakota
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Edegem
Country [8] 0 0
Belgium
State/province [8] 0 0
Kortrijk
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
China
State/province [11] 0 0
Bengbu
Country [12] 0 0
China
State/province [12] 0 0
Fuzhou
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Wuhan
Country [15] 0 0
Czechia
State/province [15] 0 0
Brno
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Dijon
Country [18] 0 0
France
State/province [18] 0 0
Saint-Herblain
Country [19] 0 0
Germany
State/province [19] 0 0
Freiburg
Country [20] 0 0
Germany
State/province [20] 0 0
Halle (Saale)
Country [21] 0 0
Germany
State/province [21] 0 0
Stuttgart
Country [22] 0 0
Israel
State/province [22] 0 0
Jerusalem
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Aviv
Country [24] 0 0
Italy
State/province [24] 0 0
Napoli
Country [25] 0 0
Japan
State/province [25] 0 0
Aichi, Nagoya
Country [26] 0 0
Japan
State/province [26] 0 0
Chiba, Kashiwa
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa, Yokohama
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka, Osaka
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Incheon
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seongnam
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Mexico
State/province [32] 0 0
Ciudad de Mexico
Country [33] 0 0
Mexico
State/province [33] 0 0
Mexico
Country [34] 0 0
Mexico
State/province [34] 0 0
Zapopan
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Netherlands
State/province [36] 0 0
Rotterdam
Country [37] 0 0
Spain
State/province [37] 0 0
Badalona
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Pamplona

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, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing


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/NCT04958239