A multicenter, open-label, dose escalation, Phase I study of LJM716 administered intravenously in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer or gastric cancer (CLJM716X2102) - CLJM716X2102

ovartis Pharma BV0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Patients (>18yr) with histologically or cytologically confirmed diagnosis of breast cancer, or patients with documented cytologically or histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. Patients must have metastatic or locally advanced-unresectable disease.
•2. an Eastern Cooperative Oncology Group (ECOG) performance status of * 2.
•3. At least one prior trastuzumab-containing regimen.
•4. Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti-HER2-based regimens, with documented progression on the most recent regimen which must contain trastuzumab or lapatinib
•5. Gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti-HER2-based regimens, with documented progression on the most recent regimen which must contain trastuzumab.
•During the dose expansion part of the study:
•6. Baseline tumor tissue must be obtained by biopsy
•7. In dose expansion only, patients must have measurable disease as defined by RECIST v1.1 (at least one lesion * 10 mm in at least one dimension when assessed by CT or MRI, or a cutaneous lesion with clearly defined margins that measures * 10 mm in at least one dimension)

•* Untreated and/or symptomatic CNS metastasis (see protocol page 32 for exceptions).
•* No archival tumor sample available or tumor sample readily obtainable.
•* Prior anti-HER3 treatment.
•* Patients who have received systemic antineoplastic therapy or any investigational therapy within 4-6 weeks (see protocol page 32 for details).
•* Major surgery within 28 days before study treatment.
•* Radiotherapy within 2 weeks prior to the first dose of study treatment except localized radiation therapy for symptomatic bone metastasis.
•* Active infection requiring systemic therapy within 10 days before study treatment.
•* Known history of HIV or active infection with hepatitis B or C virus.
•* Impaired cardiac function (see protocol page 32-33 for details).
•* Pregnancy, lactation, inadequate contraception.

发起方

ovartis Pharma BV