A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma

NCT05324501 | Terminated Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: MTX110-102
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Safety of MTX110 administered by CED

  The frequency and nature of adverse events, serious adverse events and dose limiting toxicities (DLTs).

  Through study completion, an expected average of 28 weeks. DLT period 28 days from first dose.

• To determine the recommended Phase 2 dose (RP2D) of MTX110

  Through study completion, an expected average of 28 weeks

Secondary Outcomes (3)

• Overall survival

  12 months

• Progression-free survival

  6 months

• Best overall response rate

  6 months

Study Arms (2)

Cohort A: MTX-110

EXPERIMENTAL

Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.

Drug: MTX110; Device: Programmable pump and catheter system

Cohort B: MTX-110 with optional catheter repositioning

EXPERIMENTAL

Weekly dosing of MTX110 via CED until progression. At progression, optional catheter repositioning may occur, followed by continued weekly dosing of MTX110 until next progression/ unacceptable toxicity.

Drug: MTX110; Device: Programmable pump and catheter system

Interventions

MTX110 DRUG

Soluble panobinostat

Cohort A: MTX-110; Cohort B: MTX-110 with optional catheter repositioning

Programmable pump and catheter system DEVICE

To allow Convection-Enhanced Delivery (CED)

Cohort A: MTX-110; Cohort B: MTX-110 with optional catheter repositioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent glioblastoma.
• Patients must be healthy enough to tolerate surgery and general anesthesia.
• Estimated life expectancy of greater than 3 months.

You may not qualify if:

• Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour.
• Patients with a history of glioblastoma treatment with carmustine or Gliadel® wafers.
• Patients who cannot undergo MRI.
• Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks, or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week) prior to starting the study drug.
• Patients may not have received treatment with tumor treating fields ≤ 1 week prior to starting the study drug.
• Patients may not be less than 12 weeks from completion of radiation therapy for the primary tumor.
• Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active; multifocal disease; extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease.
• Posterior fossa location of the tumor, regardless of its morphology.
• Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment).

Sponsors & Collaborators

• Biodexa Pharmaceuticals: lead

Study Sites (2)

Baptist MD Anderson

Jacksonville, Florida, 32207, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Gary Shangold

  Biodexa Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two cohort 3+3 design. Between 4-18 patients per cohort.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 12, 2022
• Study Start: October 19, 2022
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (2)