Jump to Header Jump to Main Content Jump to Footer

Ph I AMG 794 Subj w/Claudin 6-Positive Non-Squamous Epithelial Ovarian Cancer

Krishnansu Tewari


A Study On:

  • Cervix
  • Corpus Uteri
  • Ovary
  • Other Female Genital

Status:

Eligibility

Adults

Interested in joining this trial?

Official Title

Phase I First-in-Human Study to Explore the Safety, Tolerability and Pharmacokinetics of AMG 794 in Subjects with Claudin 6-Positive Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer or Epithelial Ovarian Cancer

Details

The primary objectives of this study are to evaluate the safety and tolerability of AMG 794 in adult participants and to determine the optimal biological active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose


Eligibility

You can join if...

Inclusion Criteria:
-Available positive test result for claudin 6 expression resulting from testing of an available archival tissue sample in pre-screening or obtained from biopsy in a screening procedure.
-Life expectancy > 3 months
-Adequate organ functions

Exclusion Criteria:
-Positive test for human immunodeficiency virus, hepatitis B or hepatitis C.
-History of other malignancy within the past 2 years.
-Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, (e.g., ulcerative colitis, Crohn's disease). Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.

Get in touch with our study team