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

Recruiting now · Phase 1/Phase 2

Conditions studied: Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer, Colorectal Cancer, Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Melanoma, Merkel Cell Carcinoma, Microsatellite Instability-High Solid Malignant Tumor, Mismatch Repair Deficient Solid Malignant Tumor, Microsatellite Instability-High Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Small Cell Lung Cancer, Squamous Cell Carcinoma, Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT06047379

Run by

Neonc Technologies, Inc.

People needed

134

Starts

2023-11-01

Expected to finish

2027-08-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• If progression of disease occurs within 90 days or conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection.
• Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.
• Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Patient must have an expected survival or at least three months.
• Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.
• Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.
• Patients must be able to comply with all study assessments.
• If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.
• Patient must have adequate organ and marrow function as follows:
• Absolute neutrophil count ≥ 1,500/microliter
• Platelets ≥ 100,000/microliter
• Total bilirubin within normal institutional limits
• AST (SGOT) / ALT (SPGT) ≤ 2.5 x institutional upper limit of normal
• Creatinine clearance (CrCl) of >60 mL/min (using the Cockcroft-Gault formula or 24- hour urine collection).
• Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.
• A female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).
• A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.
• A serum pregnancy test will be repeated immediately if pregnancy is suspected.
• Phase 1: (dose escalation)

Where it is running

• Precision NextGen Oncology — Beverly Hills, California, United States (enrolling)
• OPN Healthcare, Inc — Glendale, California, United States (enrolling)
• University of Southern California — Los Angeles, California, United States (enrolling)
• MDR Core Network — Boynton Beach, Florida, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Baylor, Scott and White Research Institute — Dallas, Texas, United States (enrolling)
• Northwest Medical Specialties — Tacoma, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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