Health Trials

Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

ConditionsDiffuse Astrocytoma, IDH-MutantGlioblastoma, IDH-wildtypeBrain Metastases, AdultCervical CancerColorectal CancerEsophageal CancerEsophageal Squamous Cell CarcinomaGastric CancerGastroesophageal Junction AdenocarcinomaHead and Neck Squamous Cell CarcinomaMelanomaMerkel Cell CarcinomaMicrosatellite Instability-High Solid Malignant TumorMismatch Repair Deficient Solid Malignant TumorMicrosatellite Instability-High Colorectal CancerMismatch Repair Deficient Colorectal CancerNon-small Cell Lung CancerRenal Cell CarcinomaSmall Cell Lung CancerSquamous Cell CarcinomaUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeonc Technologies, Inc.

About this trial

This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.

The study will have three phases, Phase 1, Phase 2a and Phase 2b.

Eligibility criteria

Qualifiers

Patient must be ≥ 18yrs of age.

Patient must have the ability to understand, and the willingness to sign, a written informed consent form.

Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.

Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.

Disqualifiers

Patient in Phase 1 concurrently receiving any other antitumor therapy.

Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.

Patients with metastases to the spinal cord parenchyma.

Patients with metastases to the meninges.

Trial design

Treatments tested in this trial

  • NEO212 Oral Capsule
  • Ipilimumab
  • Pembrolizumab
  • Nivolumab
  • Regorafenib
  • Carboplatin
  • Paclitaxel
  • FOLFIRI Protocol
  • Bevacizumab

Treatment groups

134 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

6
Precision NextGen Oncology90212, Beverly HillsCalifornia, United States
OPN Healthcare, Inc91203, GlendaleCalifornia, United States
University of Southern California90033, Los AngelesCalifornia, United States
Vanderbilt University Medical Center37232, NashvilleTennessee, United States

Sponsors and collaborators

Neonc Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov