A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination with Paclitaxel versus Paclitaxel Alone in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers who have received One Prior Systemic Chemotherapy

Contact:

NCT Number:

Protocol:

AAAU8625

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II/III

This study is being done and paid for by Compass Therapeutics (Compass), a company that does drug research studies in order to develop new drugs. Compass is studying a drug called CTX-009. This is an experimental drug being developed to potentially stimulate the immune system to fight against cancer (called, the “study drug”). “Experimental” means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA) or by any other regulatory authority in any other country. This study will also use paclitaxel, which is a chemotherapy drug. The main purpose of this study is to compare the effects of using study drug along with the chemotherapy paclitaxel t

Are you Eligible? (Inclusion Criteria)

  • 18 years of age or older 2. Predicted life expectancy of at least 12 weeks 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-hCG or urine-hCG performed at the Investigator’s discretion) within 14 days of randomization 5. Signed and dated approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032