Safety and Efficacy of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CTX-009 — DRUG
  CTX-009 will be given intravenously over the course of 60 minutes (+/- 5 minutes) on an outpatient basis every 2 weeks of a 28-day cycle.
• CTX-471 — DRUG
  CTX-471 will be given intravenously over the course of 30 minutes (-5/+10) on an outpatient basis every 2 weeks of a 28-day cycle.

Study Details

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

Key Dates

Start date

May 31, 2026

Status verified

May 2026

Primary completion

May 31, 2029

Completion

May 31, 2031

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase IB Arm 1: CTX-009 monotherapy
  CTX-009 will be given intravenously at the assigned dose level on an outpatient basis every 2 weeks of a 28-day cycle.
• Experimental: Phase IB Arm 2: CTX-009 and CTX-471 combination therapy
  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.
• Experimental: Phase II Expansion Arm 1: CTX-009 monotherapy
  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.
• Experimental: Phase II Expansion Arm 2: CTX-009 and CTX-471 combination therapy
  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.

Primary Outcome Measure

Phase IB Arm 1: Toxicity as measured by number of participants with adverse events [ Time Frame: Start of treatment through 60 days after treatment (estimated to be 14 months) ]

Central Contacts

• Tanner M Johanns, MD, PhD
  314-362-9355
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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