Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
Phase 1/2
134
about 3.8 years
18+
6 sites in CA, TN, TX +1
What this study is about
Researchers are testing the safety and effectiveness of NEO212, a pill, for treating patients with brain metastases, astrocytomas (IDH-mutant or wildtype), glioblastomas (IDH-wildtype), or brain metastasis from other cancers. The trial will last approximately 1399 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Bevacizumab
- 2.Take Carboplatin
- 3.Take FOLFIRI Protocol
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
bevacizumab, carboplatin, ipilimumab (Immune checkpoint inhibitor; blocks CTLA-4 on T cells), nivolumab (Immune checkpoint inhibitor; blocks PD-1 receptor on T cells), paclitaxel (Taxane chemotherapy; stabilizes microtubules), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), regorafenib
infusion, injection (Injection), oral, injection, intravenous, oral (Oral Tablet)
Primary: Phase 1: Identify the maximum tolerated dose (MTD) of NEO212, 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, 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, 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., 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.
Oncology