CTX-009 + Paclitaxel for Biliary Tract Cancer

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Compass Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a new drug (CTX-009) combined with chemotherapy in patients with advanced biliary tract cancers who have already had other treatments and cannot have surgery. The treatment aims to boost the immune system and stop cancer cell growth.

Eligibility Criteria

Adults over 18 with advanced, metastatic or recurrent biliary tract cancers including gallbladder and ampullary cancer. They must have had previous chemotherapy, be in good physical condition (ECOG 0-1), and not be at risk of bleeding. Women must use birth control and men should too if they're not sterile.

Inclusion Criteria

My cancer is in the bile ducts and cannot be removed by surgery.

I had a procedure to drain my bile duct at least 1 week ago.

I am 18 years old or older.

+18 more

Exclusion Criteria

It's been less than 4 weeks since my last surgery and less than 2 weeks since my last radiation therapy.

I have a history of bleeding disorders or stomach/intestinal diseases.

Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

+15 more

Participant Groups

The trial is testing CTX-009 combined with Paclitaxel against Paclitaxel alone in patients who've already been treated for their cancer. It's an open-label study where everyone knows what treatment they're getting, and it's randomized to compare the results fairly.

2Treatment groups

Experimental Treatment

Active Control

Group I: CTX-009 plus PaclitaxelExperimental Treatment2 Interventions

Group II: PaclitaxelActive Control1 Intervention

Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1.