solid tumor
Conditions
Interventions
BI 770371 monotherapy and BI 770371 in combination ezabenlimab will be administered to patients
Sponsors
kanemitsu Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of DLTs in the MTD evaluation period | — |
Countries
Canada, Japan, US
Contacts
Public Contactshizuko Kawahara
Nippon Boehringer Ingelheim Co., Ltd
Outcome results
None listed