CTX-009 with standard therapy for advanced biliary tract cancers
This study is looking at a new treatment approach for unresectable or metastatic biliary tract cancer (cancer that has spread and cannot be removed by surgery). It combines a new drug called CTX-009 with the standard treatment, which includes Gemcitabine, Cisplatin, and Durvalumab. All these medicines are given through an IV (into a vein). The main goal is to see how safe this combination is and what side effects it might cause. Researchers will also look at how well the treatment prevents the cancer from growing for at least 6 months. You might be able to join if you are 18 or older and have this type of cancer. The study plans to enroll 50 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 50 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be measured throughout the study, which is expected to last an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06548412
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~50 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:GemcitabineCisplatinDurvalumabCTX-009
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
NCT06548412
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
MD Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ian Hu, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Eligibility criteria
Inclusion
absolute neutrophil count ≥1,000/mcL
platelets ≥100,000/mcL
Hemoglobin ≥ 9 g/dL.
WBC ≥ 3,000/mm3
total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN (≤5×ULN w/ hepatic metastasis)
Calculated creatinine clearance ≥ 60mL/min (determined as per Cockcroft-Gault)
Urine protein ≤ 1+ by dipstick
Serum amylase and lipase level ≤ 1.5 X ULN
Serum albumin ≥ 3.0 g/dL 7. No evidence of ongoing active infection.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients with asymptomatic and controlled brain cancer are eligible for inclusion if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 9. The effects of CTX-009 on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of CTX-009 administration. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 10. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CTX-009 administration.
Exclusion
Active hemorrhage, hemorrhagic diathesis, coagulopathy, or tumor in great arteries
History of clinically significant gastroenterological disease, such as peptic ulcer, GI bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms, and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease (IBD) 10. Active, uncontrolled autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with vitiligo, psoriasis, primary sclerosing cholangitis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. 11. Active, uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) 12. Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) within 2 weeks prior to screening, or is expected to need those drugs during the clinical study. 13. A history of the following cardiovascular diseases in past 5 years:
Congestive heart failure (CHF) that corresponds to Class II or a higher class (or less than 50% of left ventricular ejection fraction (LVEF)) under New York Heart Association (NYHA) classification.
Uncontrolled hypertension (SBP/DBP \>140/90 mmHg) (e.g., patient with SBP/DBP \>140/90 mmHg despite the best care including optimizing the anti-hypertensive medication regimen)
History of hypertensive crisis or pre-existing hypertensive encephalopathy
Pulmonary hypertension
Myocardial infarction
Uncontrolled arrythmia
Unstable angina 14. Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product. 15. History of hypersensitivity reactions to any components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody drugs) 16. Patients who are receiving any other investigational agents. 17. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab. Note: While enrolled, patients should not receive any live vaccines while receiving durvalumab and up to 30 days after last dose of durvalumab. 18. Patients who experience any grade 3-4 gastrointestinal (GI) bleeding within 3 months preceding Day 1 19. Diagnosis of hepatic encephalopathy 20. History of malignant bowel obstruction 21. Patients with psychiatric illness/social situations that would limit compliance with study requirements 22. Pregnant women are excluded from this study because CTX-009 is a recombinant bispecific antibody with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CTX-009, breastfeeding should be discontinued if the mother is treated with CTX-009. These potential risks may also apply to other agents used.
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0