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Also known as NEO212 Oral Capsule
NEO212 · 1 trial · 21 indications
As determined by incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0
Maximum Tolerated Dose of NEO212 as determined by the dose escalation rules.
Determine the recommended Phase 2 dose (RP2D) of NEO212
Determined by incidence and severity of adverse events determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).
Determine the intracranial progression-free survival rate at six months (PFS6) of orally administered NEO212 alone in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype.
Determine the intracranial progression-free survival rate at six months (PFS6) of orally administered NEO212 in combination with select SOC regimens in patients with select solid tumors (see Appendix 2) with uncontrolled metastases to the brain.
| Arm | Type | Description |
|---|---|---|
| Phase 2a Safety Run-In - NEO212 and Ipilimumab | EXPERIMENTAL | \- Unresectable or metastatic melanoma with uncontrolled metastases to the brain. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Ipilimumab - 3 mg/kg administered IV over 90 minutes every 3 weeks for a maximum of 3 doses per package insert. |
| Phase 2a Safety Run-In - NEO212 and Pembrolizumab | EXPERIMENTAL | The following primary cancers with uncontrolled metrastases to the brain: * Unresectable or metastatic melanoma. * NSCLC expressing PD-L1, with no EGFR or ALK genomic tumor aberrations. * Metastatic NSCLC whose tumors express PD-L1. * EGFR or ALK genomic tumor aberrations must have disease progression. * SCLC. * Unresectable, recurrent HNSCC whose tumors express PD-L1. * HNSCC on or after platinum-containing chemotherapy. * Urothelial carcinoma whose tumors express PD-L1. * Urothelial carcinoma. * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). * Microsatellite Instability-high or Mismatch Repair Deficient Colorectal Cancer (CRC). * Gastric or gastroesophageal junction adenocarcinoma. * Esophageal or gastroesophageal juncUon (GEJ). * Cervical cancer. * Merkel cell carcinoma. NEO212 - Same as Arm 1. Pembrolizumab - 200 mg administered every 3 weeks per package insert. |
| Phase 2a Safety Run-In - NEO212 and Nivolumab | EXPERIMENTAL | The following primary cancers with uncontrolled metrastases to the brain: * Unresectable or metastatic melanoma. * Metastatic non-small cell lung cancer. * Advanced renal cell carcinoma. * Squamous cell carcinoma of the head and neck. * Urothelial carcinoma. * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. * Unresectable esophageal squamous cell carcinoma (ESCC). NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Nivolumab - 240 mg administered every 2 weeks per package insert |
| Phase 2a Safety Run-In - NEO212 and Stivarga (Regorafenib) | EXPERIMENTAL | \- Colorectal cancer (CRC) with uncontrolled metastases to the brain who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anU-EGFR therapy. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Stivarga - 160 mg orally, once daily for the first 21 days of each 28-day cycle per package insert |
| Phase 2a Safety Run-In - NEO212 and CarbolaUn (ParaplaUn) + Paclitaxel (Taxol) | EXPERIMENTAL | \- Colorectal cancer (CRC) with uncontrolled metastases to the brain. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. Carboplatin - 300 mg/m2 IV on day 1 every 4 weeks for 6 cycles per package insert. Paclitaxel - 135mg/m2 IV administered over 24 hours, every 3 weeks per package insert. |
| Phase 2a Safety Run-In - NEO212 and FOLFIRI (Zaltrap) + Bevacizumab (Avastin) | EXPERIMENTAL | \- Metastatic colorectal cancer (mCRC) with uncontrolled metastases to the brain, that is resistant to or has progressed following an oxaliplatin-containing regimen NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. FOLFIRI - 4 mg/kg aIV over 1 hour every 2 weeks. Bevacizumab - 10 mg/kg IV every 2 weeks. |
| Phase 2b efficacy - NEO212 for Astrocytoma IDH-mutant and Glioblastoma IDH-wildtype | EXPERIMENTAL | Patients receiving NEO212 alone for treatment of Astrocytoma IDH-mutant and Glioblastoma IDH-wildtype. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. |
| Phase 2b efficacy - NEO212 & SOC for Uncontrolled Metastases to the Brain | EXPERIMENTAL | Patients receiving NEO212 in combination with select standard of care treatments for treatment of uncontrolled metastases to the brain. NEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules. SOC treatments established to be safe in Phase 2a of the study will be used in this arm of Phase 2b. |
| Name | Type | Description |
|---|---|---|
| NEO212 Oral Capsule | DRUG | NEO212 is a novel chemical entity that was generated by covalent conjugation of temozolomide (TMZ) with perillyl alcohol (POH). |
| Ipilimumab | DRUG | 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. |
| Pembrolizumab | DRUG | 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. |
| Nivolumab | DRUG | Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer. |
| Regorafenib | DRUG | 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 |
| Carboplatin | DRUG | 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. |
| Paclitaxel | DRUG | 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 |
| FOLFIRI Protocol | DRUG | 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. |
| Bevacizumab | DRUG | 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 |
Inclusion Criteria: * 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 toxici...
NEO212 is an investigational small molecule being studied for the treatment of diffuse astrocytoma, IDH-mutant, a type of brain tumor. It is also being evaluated in a clinical trial for glioblastoma, IDH-wildtype, brain metastases, and several other solid tumors including non-small cell lung cancer, melanoma, and colorectal cancer.
NEO212 is a small molecule therapeutic being developed by NeOnc Technologies Holdings, Inc. for oncology indications. The specific molecular target of NEO212 has not been disclosed in the available clinical trial information, so its precise mechanism of action is not publicly detailed.
NEO212 is being developed by NeOnc Technologies Holdings, Inc., a biopharmaceutical company traded under the ticker symbol NTHI. The company is conducting clinical research on this investigational small molecule for the treatment of brain tumors and other solid tumor types.
NEO212 is currently in Phase 1 clinical development. It is an investigational drug that has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to facilitate development and expedite review of therapies for serious conditions.
NEO212 is being studied in a Phase 1 clinical trial with the identifier NCT06047379. This trial is recruiting participants in the United States and is evaluating the safety and efficacy of NEO212 in patients with astrocytoma IDH-mutant, glioblastoma IDH-wildtype, brain metastases, and various other solid tumors. The trial has a target enrollment of 134 participants.
Yes, NEO212 is also known as NEO212 Oral Capsule. The drug is being developed by NeOnc Technologies Holdings, Inc. under the name NEO212, and the oral capsule formulation is the form being evaluated in clinical trials for the treatment of certain brain tumors and other cancers.