CTX-009 + Standard Treatment for Biliary Tract Cancer

Palo Alto (17 mi)

Overseen byIan Hu, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.

Eligibility Criteria

This trial is for patients with biliary tract cancers that cannot be removed by surgery or have spread. Participants must meet certain health standards, which are not specified here.

Inclusion Criteria

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

My bile duct cancer cannot be removed by surgery and has spread or come back.

I do not have any current infections.

Exclusion Criteria

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

I have an ongoing, untreated inflammatory bowel condition.

I have had heart disease within the last 5 years.

I have been treated for my current cancer before.

I have been diagnosed with hepatic encephalopathy.

I have had active lung disease affecting the tissue and space around the air sacs of my lungs.

I have a history of lung scarring or inflammation not caused by infections.

I have not had major surgery in the last 28 days.

My brain metastasis is causing symptoms or is not under control.

I have an autoimmune disease that is not under control.

I have had a blockage in my intestines caused by cancer.

I have had severe GI bleeding in the last 3 months.

I do not have any active infections needing treatment, except for HBV or HCV.

Treatment Details

The study tests a new treatment combo: CTX-009 plus standard drugs Gemcitabine and Cisplatin, along with Durvalumab, to see if it's better as a first-line therapy for these cancer patients.

2Treatment groups

Experimental Treatment

Group I: Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatinExperimental Treatment4 Interventions

Participants will be administered treatment on an outpatient basis

Group II: Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatinExperimental Treatment4 Interventions

Participants will be administered treatment on an outpatient basis