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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06548412
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Given by IV
  • Cisplatin — DRUG
    Given by IV
  • Durvalumab — DRUG
    Given by IV
  • CTX-009 — DRUG
    Given by IV

Study Details

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

Key Dates

Start date
Jan 22, 2025
Status verified
Jan 2026
Primary completion
May 1, 2027
Completion
May 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin
    Participants will be administered treatment on an outpatient basis
  • Experimental: Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin
    Participants will be administered treatment on an outpatient basis

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Ian Hu, MD
[email protected]
713-792-2828
Ian Hu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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