Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors
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Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females \>=18 years of age (at the time consent is obtained).
Written informed consent provided.
Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
Sufficient archival tumor specimen is available for HER3 immunohistochemistry (IHC) analysis, or subject is willing to undergo a fresh tumor biopsy for HER3 IHC analysis.
Histologically or cytologically confirmed diagnosis of one of the following solid tumor malignancies for which no standard therapeutic alternatives exist: bladder cancer, breast cancer, castrate-resistant prostate cancer, cervical cancer, colorectal cancer (CRC), gastric cancer, hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, squamous cancers of the head and neck region (including parotid and nasopharynx).
You may not be if
Subjects with leptomeningeal or brain metastases or spinal cord compression.
Prior HER3- directed treatment (HER2- or EGFR-directed treatment is acceptable).
Concurrent medical condition that would jeopardize compliance.
Receiving chronic immunosuppressive therapies (includes daily steroid doses in excess of 20 milligrams \[mg\]/day of prednisone).
Clareo Health | Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors
