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NTHINeonc Technologies, Inc.Signing up patients

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

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

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 1/2
Patients
134 (planned)
Started
Nov 1, 2023
Main results expected
Feb 28, 2027
Fully finished
Aug 31, 2027
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Phase 1: safety and tolerability of increasing dose levels of orally administered NEO212 alone in patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or patients with select solid tumors with uncontrolled metastases to the brain

    Measured over: 6 months

  • Phase 1: Identify the maximum tolerated dose (MTD) of NEO212

    Measured over: 6 months

  • Phase 1: Determine the recommended Phase 2 dose (RP2D) of NEO212

    Measured over: 6 months

  • Phase 2a: Assess the safety and tolerability of orally administered NEO212 in combination with select SOC regimens following a standard 3+3 design in patients with select solid tumors with uncontrolled metastases to the brain

    Measured over: 6 months

  • Phase 2b: 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.

    Measured over: 6 months

  • Phase 2b: 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 with uncontrolled metastases to the brain.

    Measured over: 6 months

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

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Raw record changes

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Trial ID NCT06047379 · record last updated 2026-09-24 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT06047379) ↗