臨床研究等提出・公開システム

An open-label, Phase I dose escalation followed by dose expansion trial in patients with advanced solid tumours to investigate safety, pharmacokinetics, and efficacy and to select the dose for further development of BI 770371 in combination with ezabenlimab

A study in people with advanced cancer to test how well different doses of BI 770371 alone or in combination with ezabenlimab are tolerated

kanemitsu Jun

Nippon Boehringer Ingelheim Co., Ltd

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

medchiken.jp@boehringer-ingelheim.com

Kawahara shizuko

Nippon Boehringer Ingelheim Co., Ltd

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

+81-120-189-779

shizuko.kawahara@boehringer-ingelheim.com

Recruiting

July. 20, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
- Presence of at least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Score: 0 to 1
- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options (including anti-PD-1 or anti-PD-L1 therapies, if relevant). Patients must have exhausted available treatment options known to prolong survival for their disease

- Presence of active invasive cancers other than the one treated in this trial within 5 years prior to screening, with the exception of appropriately treated basal-cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment
- Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of PD by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases
- History of pneumonitis within the last 5 years or Interstitial lung disease
- History of severe hypersensitivity reactions and/or severe infusion related reactions (Grade >= 3 NCI CTCAE v5.0) to other mAbs
- Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 6 months after the last dose of trial treatment

Both

solid tumor

BI 770371 monotherapy and BI 770371 in combination ezabenlimab will be administered to patients

Occurrence of DLTs in the MTD evaluation period

+81-3-3542-2511

June. 15, 2022

No

US/Canada