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.
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
Drug | Synonyms | Arms |
---|
NUV-422 | | Phase 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
Name | Type | Description | Interventions |
---|
Phase 1 Dose Escalation | Experimental | NUV-422 administered at escalating dose levels until the maximum tolerated dose (MTD) is reached. | |
Phase 2 Dose Expansion | Experimental | NUV-422 administered at the recommended Phase 2 dose (RP2D). | |
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
November 30, 2020