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)
- Conditions
- breast cancer or gastric cancer10006291
- Registration Number
- NL-OMON37081
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of dose-limiting toxicities.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Adverse events, PK parameters, post-treatment change from baseline in pHER3<br /><br>levels in tumor and skin, PK/PD, Overall Response Rate, Progression Free<br /><br>Survival and Duration of Response, antibodies against LJM716.</p><br>