Evaluation of Ascorbate-Meglumine Therapeutic for SRS

NCT06433791 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 1 other identifier: LadeRX
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)

Conditions

Safety

Outcome Measures

Primary Outcomes (1)

• Safety as measured by adverse events

  Adverse events will be monitored in patients receiving ascorbate-meglumine during Stereotactic Radiosurgery (SRS)

  1 week after receiving study drug with SRS

Study Arms (4)

Ascorbate Meglumine dose 1

EXPERIMENTAL

Patients receiving Stereotactic Radiosurgery (SRS) treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced Magnetic Resonance Imaging (MR) scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases. The first cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.16 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine

Drug: Ascorbate-Meglumine

Ascorbate Meglumine dose 2

EXPERIMENTAL

Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases.The second cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.31 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine

Drug: Ascorbate-Meglumine

Ascorbate Meglumine dose 3

EXPERIMENTAL

Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, includingpost-operative patients with 1-3 residual metastases. The third cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.63 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine

Drug: Ascorbate-Meglumine

Ascorbate Meglumine dose 4

EXPERIMENTAL

Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, includingpost-operative patients with 1-3 residual metastases. The fourth cohort of patients will receive ascorbate-meglumine at a dose administration rate of 1.25 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine

Drug: Ascorbate-Meglumine

Interventions

Ascorbate-Meglumine DRUG

Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate,125 mM ascorbic acid and 125 mM meglumine in sterile water for injection

Also known as: Vitamin C

Ascorbate Meglumine dose 1; Ascorbate Meglumine dose 2; Ascorbate Meglumine dose 3; Ascorbate Meglumine dose 4

Eligibility Criteria

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

You may qualify if:

• Primary cancer diagnosis with newly diagnosed brain metastases
• Diagnostic MRI demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases.
• Maximum tumor diameter ≤ 2.5 cm for the largest lesion determined during the planning MRI
• Plan of care must include Stereotactic Radiosurgery (SRS)
• SRS treatment plan must be delivered as a single RT fraction
• Age 18 years and older
• Life expectancy of at least 3 months
• GPA score 0.5 or greater
• Capable of providing written informed consent to participate in the study

You may not qualify if:

• Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma)
• Metastases in the brain stem, pons or medulla or within 3 mm of the optic apparatus (such that some portion of the optic nerve or chiasm would receive a radiation dose \> 10 Gy SRS in one single fraction)
• Previous whole-brain radiation (previous SRS to or resection of other brain lesions is permitted if more than 3 months prior to the date of enrollment on this protocol)
• Pregnancy
• History or manifestation of glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency
• History of oxalate kidney stones
• History of iron overload or hemochromatosis
• History of allergy to ascorbic acid
• Anuria, dehydration, serum albumin \<3.0 g/dL, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated .
• Subjects who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide.
• Subjects who are on strong inducers, inhibitors or substrates of CYP within 3 days of planned administration of study ascorbate-meglumine.
• Subjects for which MRI is contra-indicated (for example a pacemaker/recent surgery with orthopedic prosthesis)

Sponsors & Collaborators

• LadeRx LLC: lead
• Duke Clinical Research Institute: collaborator

Study Sites (1)

Duke Health

Durham, North Carolina, 27709, United States

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• John Kirkpatrick, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

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: dose escalation

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: September 9, 2024
• Primary Completion: May 17, 2025
• Study Completion: September 9, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)