臨床研究等提出・公開システム

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)

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

Tahara Eriko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Katakabe Tetsuya

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Mar. 15, 2022

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

Phase Ia:
Not currently recruiting, so this is omitted.
Phase Ib:
1.Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent HNSCC
2.No prior systemic therapy administered in the metastatic or incurable, recurrent setting
3.Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx

Phase Ia:
Not currently recruiting, so this is omitted.
Phase Ib:
1.Disease suitable for local therapy administered with curative intent
2.Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology)
3.Life expectancy of <3 months and/or has rapidly progressing disease

Both

Phase Ia:Advanced solid cancers
Phase Ib:Head and neck squamous cell carcinoma

Phase Ia:
Arm A: BI 765179 dosed once q3w
Arm B: BI 765179 dosed q3w in combination with ezabenlimab administered q3w
Phase Ib:
pembrolizumab (q3w) + BI 765179 (qw3)

Phase Ia:
-The MTD, defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to CTCAE version 5.0, during the MTD evaluation period.
-Number of patients experiencing DLTs in the MTD evaluation period.
Phase Ib:
-Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 by Investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

Phase Ia:
-Number of patients experiencing DLTs during the on-treatment period (per arm)
-The following PK parameters of BI 765179 will be evaluated after the first and after multiple administrations of -BI 765179 in both treatment arms:
- Cmax(,ss)
- AUC0-504(,ss)
Phase Ib:
-Occurence of AEs during the on-treatment period using NCI CTCAE v5
-Occurence of SAEs during the on-treatment period
-OR assessed by the Investigator according to iRECIST, defined as best overall response of iCR and iPR, where the best overall response is the best time point response recorded from the first administration of study medication until the end of treatment

+81-3-3542-2511

Feb. 02, 2022

No

USA/Belgium/Spain/Netherlands