CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers

NCT06548412 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2024-0279NCI-2024-06735
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (2)

Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin

EXPERIMENTAL

Participants will be administered treatment on an outpatient basis

Drug: Gemcitabine; Drug: Cisplatin; Drug: Durvalumab; Drug: CTX-009

Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin

EXPERIMENTAL

Participants will be administered treatment on an outpatient basis

Drug: Gemcitabine; Drug: Cisplatin; Drug: Durvalumab; Drug: CTX-009

Interventions

Gemcitabine DRUG

Given by IV

Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin; Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin

Cisplatin DRUG

Given by IV

Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin; Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin

Durvalumab DRUG

Given by IV

Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin; Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin

CTX-009 DRUG

Given by IV

Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin; Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to understand and the willingness to sign a written informed consent document.
• Histologically or cytologically confirmed (outside pathology reports will be accepted) unresectable advanced, metastatic, or recurrent BTC at the time of enrollment that has not been previously treated in the metastatic setting.
• Patients must have measurable disease per RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
• ECOG performance status ≤2
• Patients must have adequate organ and marrow function within 14 days of treatment as described below (patients must be free of G-CSF treatment within 14 days prior to the lab test)
• 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

You may not qualify if:

• Previous treatment of the current malignancy. Patients who received prior perioperative treatment (adjuvant and neoadjuvant) are eligible.
• History of active interstitial lung disease.
• History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on baseline imaging
• Major surgical intervention within 28 days of Day 1 (Biliary stent placement, biliary stent exchange, and Endoscopic retrograde cholangiopancreatography (ERCPs) are not considered major surgical interventions)
• Patients with percutaneous transhepatic biliary drains (PTBD)
• Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving). Unless symptomatic, imaging of the head is not required for screening.
• Has an active infection requiring systemic therapy, with the exception of HBV and HCV
• Known positive serology for HIV (Human immunodeficiency virus)
• A history of the following hemorrhage-related or gastroenterological disease:
• 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)
• 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.
• Active, uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
• 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.
• A history of the following cardiovascular diseases in past 5 years:

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Compass Therapeutics, Inc: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Cisplatin; durvalumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ian Hu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Hu, MD

CONTACT

(713) 792-2828; GIClinicalTrials@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)