CTX-009 + CTX-471 for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a phase IB/II, open-label study evaluating CTX-009 as monotherapy and in combination with CTX-471. The study evaluates the safety and efficacy of the monotherapy and the combination in patients with recurrent glioblastoma. The study tests the hypothesis that treatment with CTX-009 alone or in combination with CTX-471 will lead to enhanced tumor control and prolongation of overall survival of patients with recurrent glioblastoma.
CTX-009 expands on existing anti-angiogenic therapies by ablating key compensatory and resistance mechanisms to bevacizumab, CTX-471 restores local immune reactivity through activation of costimulatory immune mediators. Combination of these two agents may further impair tumor proliferation through synergistic effects on the tumor microenvironment
Who Is on the Research Team?
Tanner M Johanns, MD, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for patients with recurrent glioblastoma, a type of brain cancer. Participants should have experienced the return of their cancer after previous treatments. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior therapies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
CTX-009 is administered as monotherapy or in combination with CTX-471 in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- CTX-009
- CTX-471
Trial Overview
The study is testing CTX-009 alone or combined with CTX-471 to see if they can better control tumor growth and extend survival in recurrent glioblastoma patients. It's an early-stage trial (phase IB/II) that's open-label, meaning everyone knows which treatment they're getting.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
CTX-009 will be given intravenously at the dose determined to be the recommended phase II dose (RP2D) every 2 weeks (day 1 and day 15). CTX-471 will be given intravenously at a dose of 0.3 mg/kg every 2 weeks (day 1 and day 15). On days when both drugs are given, CTX-009 will be given first, followed by a 30-minute observation period, followed by CTX-471. Cycles will be 28 days.
CTX-009 will be given intravenously at the recommended phase 2 dose (RP2D) determined from Phase IB on an outpatient basis every 2 weeks of a 28-day cycle.
CTX-009 will be given intravenously at the dose determined to be the recommended phase II dose (RP2D) in Arm 1 every 2 weeks, and CTX-471 will be given intravenously at a dose of 0.3 mg/kg every 2 weeks (day 1 and day 15). On days when both drugs are given, CTX-009 will be given first, followed by a 30-minute observation period, followed by CTX-471. Cycles will be 28 days.
CTX-009 will be given intravenously at the assigned dose level on an outpatient basis every 2 weeks of a 28-day cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
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