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

ConditionsDiffuse 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
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeonc Technologies, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.

Disqualifiers

Patient in Phase 1 concurrently receiving any other antitumor therapy.

Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.

Patients with metastases to the spinal cord parenchyma.

Patients with metastases to the meninges.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

134 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Phase 2a Safety Run-In - NEO212 and IpilimumabExperimental treatment 2 interventions
Group B: Phase 2a Safety Run-In - NEO212 and PembrolizumabExperimental treatment 2 interventions
Group C: Phase 2a Safety Run-In - NEO212 and NivolumabExperimental treatment 2 interventions
Group D: Phase 2a Safety Run-In - NEO212 and Stivarga (Regorafenib)Experimental treatment 2 interventions
Group E: Phase 2a Safety Run-In - NEO212 and CarbolaUn (ParaplaUn) + Paclitaxel (Taxol)Experimental treatment 3 interventions
Group F: Phase 2a Safety Run-In - NEO212 and FOLFIRI (Zaltrap) + Bevacizumab (Avastin)Experimental treatment 3 interventions
Group G: Phase 2b efficacy - NEO212 for Astrocytoma IDH-mutant and Glioblastoma IDH-wildtypeExperimental treatment 1 intervention
Group H: Phase 2b efficacy - NEO212 & SOC for Uncontrolled Metastases to the BrainExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

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

As determined by incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0

Time frame
6 months
2

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

Maximum Tolerated Dose of NEO212 as determined by the dose escalation rules.

Time frame
6 months
3

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

Determine the recommended Phase 2 dose (RP2D) of NEO212

Time frame
6 months
4

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

Determined by incidence and severity of adverse events determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neonc Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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