gastric/gastroesophageal cancer head and neck cancer or NSCLC stage III-IV melanoma
Conditions
Interventions
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Written informed consent obtained. • Males and females >=18 years of age. • ECOG status 0 or 1. • Sufficient archival tumor specimen is available for HER3 (± NRG1) analysis or willingness to provide fresh tumor sample. • Previously treated, unresectable stage III-IV melanoma, gastric/gastroesophageal cancer, head and neck cancer, or non small cell lung cancer, who are HER3 positive or (HN cancer or NSCLC) HER3 and NRG1 positive, see protocol page 23-25 for details. • Adequate contraception for females of childbearing potential (see protocol page 22-23 for details). • Men with a female partner of childbearing potential must agree to use effective contraception (see protocol page 23 for details).
Exclusion criteria
Exclusion criteria: • Untreated brain or meningeal metastases or spinal cord compression (see protocol page 25 for details). • Prior HER3- directed treatment. • Use of a prohibited medication (see protocol section 10.2). • Evidence of significant cardiovascular risk (see protocol page 26 for details). • Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug plasma concentration, antibodies against GSK2849330, response evaluation (RESIST 1.1). | — |
Countries
The Netherlands
Outcome results
None listed