CTX-009 with or without CTX-471 for recurrent glioblastoma

10 evidence topics · 1 source

Objective

Registered objective

“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.” (opens the source at this quote in a new tab)

Mechanistic hypothesis

“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.” (opens the source at this quote in a new tab)

Location and study date

Study dates, status, and site: registry record

Milestone	Registry record
Study start (actual)	“2026-06-16”
Primary completion (estimated)	“2029-06-30”
Enrollment (estimated)	“54”
Recruitment status	“Recruiting”
Last update posted	“2026-06-22”

Sponsoring institution and site

“Washington University School of Medicine” (opens the source at this quote in a new tab)
“St Louis, Missouri, United States” (opens the source at this quote in a new tab)

Study design

Sequential enrollment of the monotherapy and combination arms

“After completion of enrollment to Arm 1 (phase IB and phase II), enrollment will open to Arm 2.” (opens the source at this quote in a new tab)

Eligibility criteria

Key inclusion criteria: registry record

Criterion	Quoted registry text
Diagnosis	“Histologically or radiographically confirmed recurrent CNS WHO grade 4 IDH wild-type glioma following standard of care treatment including radiation, chemotherapy, and/or tumor-treating fields. No more than 2 recurrences are allowed.”
Age	“At least 18 years of age.”
Performance status	“KPS performance status ≥ 60%”

Treatment

Registered dosing of CTX-009

“CTX-009 will be given intravenously at the assigned dose level on an outpatient basis every 2 weeks of a 28-day cycle.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using overall survival rate at 12 months as the primary endpoint

Registered primary outcome measures

Outcome measure	Measure description	Time frame
“Phase IB Arm 1: Recommended Phase 2 Dose (RP2D)”	“RP2D will be determined from the phase IB portion of Arm 1 by assessing tolerability.”	“Start of treatment through completion of cycle 1 (each cycle is 28 days)”
“Phase II Arm 1: Overall survival rate at 12 months (OS12)”	“Overall survival is defined from time of treatment start to time of death due to any cause or latest follow-up, whichever is earlier, with an inference focus on 12-month overall survival.”	“12 months”
“Phase II Arm 2: Overall survival rate at 12 months (OS12)”	“Overall survival is defined from time of treatment start to time of death due to any cause or latest follow-up, whichever is earlier, with an inference focus on 12-month overall survival.”	“12 months”

Justification of the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

“54” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

This is an investigator-sponsored phase 1b/2 trial at one institution in recurrent glioblastoma, not biliary tract cancer, with an estimated enrollment of 54 participants. The two arms enroll sequentially rather than concurrently, so the monotherapy and combination arms are not randomized against each other. The trial began on June 16, 2026 with estimated primary completion on June 30, 2029, and no results had been posted as of the June 22, 2026 registry update. The phase 2 primary outcome is the 12-month overall survival rate in each arm without a control group, so it will be interpreted against external benchmarks.