RECRUITING

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

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Conditions

Diffuse 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 CarcinomaAstrocytomaIDH-mutantGlioblastomaIDH-wildtypeBrain MetastasesCNS TumorGBMNeOncAnovaNEO212NEO100TMZ

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

Quick Facts

Study Start:2023-11-01
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06047379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be ≥ 18yrs of age.
  2. * Patient must have the ability to understand, and the willingness to sign, a written informed consent form.
  3. * Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.
  4. * Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.
  5. * If progression of disease occurs within 90 days or conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection.
  6. * Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.
  7. * Patient with select solid tumors (see Appendix 2) must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  8. * Patient must have an expected survival or at least three months.
  9. * Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.
  10. * Patient with select solid tumors (see Appendix 2) must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.
  11. * Patients must be able to comply with all study assessments.
  12. * If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.
  13. * Patient must have adequate organ and marrow function as follows:
  14. * Absolute neutrophil count ≥ 1,500/microliter
  15. * Platelets ≥ 100,000/microliter
  16. * Total bilirubin within normal institutional limits
  17. * AST (SGOT) / ALT (SPGT) ≤ 2.5 x institutional upper limit of normal
  18. * Creatinine clearance (CrCl) of \>60 mL/min (using the Cockcroft-Gault formula or 24- hour urine collection).
  19. * Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.
  20. * Has not undergone a hysterectomy or bilateral oophorectomy; or
  21. * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).
  22. * A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.
  23. * A serum pregnancy test will be repeated immediately if pregnancy is suspected.
  24. * Patient must:
  25. * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or
  26. * have select solid tumors (see Appendix 2) with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.
  27. * Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:
  28. * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;
  29. * 2 weeks from administration of immunotherapies;
  30. * 28 days from administration of cytotoxic agents; and
  31. * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).
  32. * Patient must have select solid tumors (see Appendix 2) with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.
  33. * Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens listed on Appendix 1.
  34. * Patient must have measurable/evaluable CNS disease per RANO or RANO-BM criteria.
  35. * Patient must have measurable/evaluable systemic disease per RECIST v1.1 criteria.
  36. * Patient must:
  37. * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or
  38. * have select solid tumors (see Appendix 2) with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.
  39. * Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens listed on Appendix 1.
  40. * Patient must have measurable/evaluable CNS disease per RANO or RANO-BM criteria
  41. * Patient with select solid tumors (see Appendix 2) must have measurable/evaluable systemic disease per RECIST v1.1 criteria.
  42. * Creatinine clearance (CrCl) of \>60 mL/min (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.
  43. 9.2
  1. * Patient in Phase 1 concurrently receiving any other antitumor therapy.
  2. * Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.
  3. * Patients with metastases to the spinal cord parenchyma.
  4. * Patients with metastases to the meninges.
  5. * Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.
  6. * Patient with history of known leptomeningeal involvement.
  7. * Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.
  8. * Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and/or the use of concomitant medications that prolong QT/QTc interval.
  9. * Patient had surgery within 7 days prior to the date of informed consent.
  10. * Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.
  11. * Patient had prior treatment with perillyl alcohol.
  12. * Patient has a history of allergic reactions attributed to perillyl alcohol.
  13. * Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his/her primary CNS tumor(s).

Contacts and Locations

Study Contact

Christopher Beardmore
CONTACT
224 218 2408
chris@anovaevidence.com
Chloe Richmond
CONTACT
224 218 2408
chloe@anovaevidence.com

Principal Investigator

Tom Chen, MD, PhD
STUDY_CHAIR
NeOnc Technologies
Vincent Simmons, PhD
STUDY_DIRECTOR
NeOnc Technologies
Patrick Walters
STUDY_DIRECTOR
NeOnc Technologies

Study Locations (Sites)

Precision NextGen Oncology
Beverly Hills, California, 90212
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Neonc Technologies, Inc.

  • Tom Chen, MD, PhD, STUDY_CHAIR, NeOnc Technologies
  • Vincent Simmons, PhD, STUDY_DIRECTOR, NeOnc Technologies
  • Patrick Walters, STUDY_DIRECTOR, NeOnc Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • Astrocytoma
  • IDH-mutant
  • Glioblastoma
  • IDH-wildtype
  • Brain Metastases
  • CNS Tumor
  • GBM
  • NeOnc
  • Anova
  • NEO212
  • NEO100
  • TMZ

Additional Relevant MeSH Terms

  • 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