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Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin for Biliary Tract Cancer

Phase 1 & 2
Waitlist Available
Led By Ian Hu, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CTX-009 in combination with durvalumab, gemcitabine, and cisplatin in patients \<18 years of age, children are excluded from this study.
2. Ability to understand and the willingness to sign a written informed consent document.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to Durvalumab, kidney issues from Cisplatin, and blood cell count changes from Gemcitabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Adverse Events (AEs)

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Durvalumab
2017
Completed Phase 2
~3840
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,197 Total Patients Enrolled
Compass Therapeutics, IncUNKNOWN
Ian Hu, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~33 spots leftby May 2027
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