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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2026

Conditions
Diffuse 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
Interventions
DRUG

NEO212 Oral Capsule

NEO212 is a novel chemical entity that was generated by covalent conjugation of temozolomide (TMZ) with perillyl alcohol (POH).

DRUG

Ipilimumab

Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. Cytotoxic T lymphocytes can recognize and destroy cancer cells.

DRUG

Pembrolizumab

Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is given by slow injection into a vein.

DRUG

Nivolumab

Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer.

DRUG

Regorafenib

Regorafenib, sold under the brand name Stivarga among others, is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase. Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition

DRUG

Carboplatin

Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It is used by injection into a vein.

DRUG

Paclitaxel

Paclitaxel, sold under the brand name Taxol among others, is a chemotherapy medication used to treat ovarian cancer, esophageal cancer, breast cancer, lung cancer, Kaposi's sarcoma, cervical cancer, and pancreatic cancer. It is administered by intravenous injection

DRUG

FOLFIRI Protocol

"FOLFIRI is a chemotherapy regimen for treatment of colorectal cancer. It is made up of the following drugs:~FOL - folinic acid (leucovorin), a vitamin B derivative with multiple applications, which in this context increases the cytotoxicity of 5-fluorouracil; F - fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops synthesis; and IRI - irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating."

DRUG

Bevacizumab

Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma

Trial Locations (2)

90212

RECRUITING

Precision NextGen Oncology, Beverly Hills

98405

RECRUITING

Northwest Medical Specialties, Tacoma

Sponsors
All Listed Sponsors
lead

Neonc Technologies, Inc.

INDUSTRY

NCT06047379 - Safety and Efficacy of NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis | Biotech Hunter | Biotech Hunter