Phase Ia/Ib, open-label, multicenter, dose-escalation study followed by an extension phase to evaluate the safety, pharmacokinetics and activity of RO5479599, a glycoengineered antibody against HER3, administered either alone (Part A) or in combination with cetuximab (Part B) or in combination with erlotinib (Part C) in patients with metastatic and/or locally advanced malignant HER3-positive solid tumors of epithelial cell;origin. - HER3

Roche Nederland B.V.0 个研究点目标入组 97 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Adult patients, >/= 18 years of age;• European Cooperative Oncology Group (ECOG) performance status 0-2;• Histologically confirmed metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelian origin;• Availability of tissue and willingness to perform fresh pretreatment biopsies;• Patients for whom no standard therapy exists;• Life expectancy of >= 12 weeks. ;• All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade </= 1, except for alopecia and Grade 2 peripheral neuropathy;• Adequate hematological, renal and liver function;• Patient's with Gilbert's syndrome will be eligible for the study;• Part A extension cohort: : In addition to the above inclusion criteria, patients will be eligible if they have metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelial cell origin;• Part B extension cohort: In addition to the above inclusion criteria, patients will be eligible if they have metastatic and/or locally advanced non-small cell lung cancer or squamous cell carcinoma of the head and neck or colorectal cancer (CRC must be EGFR pos. and KRAS wt).;• Part C extension cohort: In addition to the above inclusion criteria, patients will be eligible if they have metastatic and/or locally advanced squamous non-small cell lung cancer or non-squamous carcinomas with documented NRG1 somatic gene fusion

•Known or clinically suspected CNS primary tumors or metastases including leptomeningeal metastases, except for previously treated CNS metastases that are asymptomatic and did not require steroids or enzyme-inducing anticonvulsants in the last 14 days;• Evidence of significant uncontrolled concomitant diseases or disorders;• Active or uncontrolled infections;• HIV infection;• Major surgery or significant traumatic injury < 28 days prior to the 1st RO5479599 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.;• Therapy with antibody or immunotherapy concurrently or within 14 days prior to first dose of study drug;• Regular immunosuppressive therapy;• Concurrent high dose of systemic corticosteroids (> 20 mg/day dexamethasone or equivalent for > 7 consecutive days);• Baseline QTc interval of > 470 ms, patients with baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia > 100 beats per minute.

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