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

Summary

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.

Conditions

• 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

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

Sponsors & Collaborators

• Neonc Technologies, Inc.

  lead INDUSTRY

Principal Investigators

• Tom Chen, MD, PhD · NeOnc Technologies

• Josh Neman, PhD · NeOnc Technologies Holdings, Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2027-02-28

Completion

2027-08-31

FDA Drug

Yes

Countries

• United States

Study Locations