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

akahara Asuka0 个研究点目标入组 12 人开始时间: 2022年4月22日最近更新: 2023年10月17日

试验速览

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•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

发起方

akahara Asuka