Clinical Trials /

Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas

NCT04541225

Description:

NUV-422-02 is a first-in-human, open-label, Phase 1/2 dose escalation and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas. All patients will self-administer NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Related Conditions:
  • Malignant Glioma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas
  • Official Title: Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas

Clinical Trial IDs

  • ORG STUDY ID: NUV-422-02
  • NCT ID: NCT04541225

Conditions

  • Glioma
  • Glioma, Malignant
  • Glioma, Mixed
  • Glial Cell Tumors

Interventions

DrugSynonymsArms
NUV-422Phase 1 Dose Escalation

Purpose

NUV-422-02 is a first-in-human, open-label, Phase 1/2 dose escalation and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas. All patients will self-administer NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Trial Arms

NameTypeDescriptionInterventions
Phase 1 Dose EscalationExperimentalNUV-422 administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
  • NUV-422
Phase 2 Dose ExpansionExperimentalNUV-422 administered at the recommended Phase 2 dose (RP2D).
  • NUV-422

Eligibility Criteria

        Key Inclusion Criteria:

          1. Histologically confirmed diagnosis of high grade glioma

          2. Evidence of recurrence after treatment (ie, surgery, radiation, or temozolomide) or
             refractory (or intolerant) to treatment

          3. Recovered from toxicity to prior anti-cancer therapy

          4. Adequate bone marrow and organ function

          5. Life expectancy of > 3 months

        Cohort-Specific Inclusion Criteria: In addition to the inclusion criteria listed above, the
        following criteria apply based on enrollment into specific cohorts:

        Phase 1 Dose Escalation Cohorts

          1. Measurable or non-measurable disease

          2. Karnofsky Performance Status (KPS) score ≥ 60

        Phase 2 Expansion Cohort 1

          1. Available tumor tissue

          2. Received prior therapy with radiation or radiation plus temozolomide

          3. Radiographic evidence of progression and measurable disease as determined by the
             Investigator per standard criteria

          4. KPS score ≥ 70

        Phase 2 Expansion Cohort 2

          1. Received prior therapy with radiation or radiation plus temozolomide

          2. Radiographic evidence of progression and measurable disease as determined by the
             Investigator per standard criteria

          3. KPS score ≥ 70

          4. Eligible for surgical resection

        Key Exclusion Criteria:

          1. Have received chemotherapy, radiation, or biological anti-cancer therapy within 14
             days prior to the first dose of IP

          2. Has a history of or current use of bevacizumab as therapy for brain cancer

          3. Received treatment with an investigational agent for any indication within 14 days for
             non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent
             prior to enrollment

          4. Requires systemic corticosteroid therapy > 4 mg/day (> 2 mg/day for Expansion Cohort
             2) of dexamethasone or equivalent or increasing doses of systemic corticosteroids
             during the 7 days prior to enrollment

          5. Requires anti-seizure medications that are known to be strong inducers of CYP3A4/5
             enzymes (carbamazepine, phenytoin) or has a recent history of uncontrolled or
             intermittent seizures

          6. Females who are pregnant or breast feeding
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1 Dose Escalation
Time Frame:During the dose-limiting toxicity (DLT) period (28 days)
Safety Issue:
Description:Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nuvation Bio Inc.

Trial Keywords

  • Phase 1
  • Phase 2
  • malignant glioma

Last Updated

February 10, 2021