Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05510427
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

Study Details

To find the highest tolerable dose of infigratinib that can be given in combination with bevacizumab and atezolizumab to patients with advanced/metastatic CCA with a FGFR2 mutation.

Key Dates

Start date
Aug 7, 2023
Status verified
Aug 2023
Primary completion
Aug 7, 2023
Completion
Aug 7, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Dose Escalation)
    The first group of participants will receive the lowest dose level of infigratinib.
  • Experimental: Part B (Dose Expansion)
    Participants will receive infigratinib at the recommended dose that was found in Part A.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ]

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