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

JRCT ID: jRCT2031220031

Registered date:22/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: solid tumor
• Date of first enrollment: 20/07/2022
• Target sample size: 12
• Countries of recruitment: US,Japan,Canada,Japan
• Study type: Interventional
• Intervention(s): BI 770371 monotherapy and BI 770371 in combination ezabenlimab will be administered to patients

Outcome(s)

• Primary Outcome: Occurrence of DLTs in the MTD evaluation period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: kanemitsu Jun