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

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ClinicalTrials.gov Identifier: NCT04541225
Recruitment Status : Terminated (Sponsor decision)
First Posted : September 9, 2020
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Nuvation Bio Inc.

Study Description
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Brief Summary:
At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients self-administered NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Condition or disease Intervention/treatment Phase
Glioma Glioma, Malignant Glioma, Mixed Glial Cell Tumors Breast Cancer Breast Carcinoma Cancer of Breast Cancer of the Breast Breast Tumor Malignant Tumor of Breast Advanced Breast Cancer Advanced Breast Carcinoma Metastatic Breast Cancer Metastatic Breast Carcinoma Prostate Cancer Prostatic Cancer Cancer of Prostate Cancer of the Prostate Prostate Neoplasm Castrate Resistant Prostate Cancer Castration-resistant Prostate Cancer Castration Resistant Prostatic Neoplasms Glioblastoma Recurrent Glioblastoma Drug: NUV-422 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Actual Study Start Date : December 8, 2020
Actual Primary Completion Date : August 31, 2022
Actual Study Completion Date : August 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1 Dose Escalation
NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
 Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D) [ Time Frame: During the DLT period (28 days) ]
    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

For All Cohorts:

  1. Recovered from toxicity to prior anti-cancer therapy
  2. Adequate bone marrow and organ function
  3. Appropriate candidate for NUV-422 monotherapy
  4. 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.

High-Grade Glioma:

  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. Measurable or non-measurable disease
  4. Karnofsky Performance Status (KPS) score ≥ 60

HR+HER2- Metastatic Breast Cancer:

  1. Men and women who are not suitable for surgical resection or radiotherapy for the purpose of cure
  2. Diagnosis of locally advanced or HR+HER2- metastatic breast cancer
  3. Evidence of progression as determined by the Investigator per standard criteria
  4. Patients must have endocrine-resistant disease
  5. Prior therapy: At least 1 but not more than 4 prior lines of systemic therapies for locally advanced inoperable or metastatic BC including at least 1 prior line of hormonal therapy in combination with an approved CDK4/6 inhibitor
  6. Have no known active or symptomatic central nervous system (CNS) disease
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2

Metastatic Castration-Resistant Prostate Cancer:

  1. Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
  2. Evidence of disease progression as determined by Investigator per standard criteria
  3. Have no known active or symptomatic CNS disease
  4. Received prior therapy with anti-androgen(s) and taxane-based chemotherapy for castration-resistant disease
  5. ECOG PS ≤ 2

Key Exclusion Criteria for All Cohorts:

  1. Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422
  2. Has a history of or current use of bevacizumab (glioma and brain metastases only)
  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 the first dose of NUV-422
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541225


Locations
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United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
United States, Florida
Miami Cancer Institute
Miami, Florida, United States, 33176
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
United States, South Carolina
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology P.A. Austin
Austin, Texas, United States, 78705
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Oncology
Tyler, Texas, United States, 75702
United States, Utah
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Nuvation Bio Inc.
More Information
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Responsible Party: Nuvation Bio Inc.
ClinicalTrials.gov Identifier: NCT04541225    
Other Study ID Numbers: NUV-422-02
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuvation Bio Inc.:
Phase 1
malignant glioma
metastatic breast cancer
metastatic castration-resistant prostate cancer
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Glioblastoma
Glioma
Prostatic Neoplasms, Castration-Resistant
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
 Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue