GliomaPhase 1NCT04541225
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
A Phase 1 study testing NUV-422 in people with Glioma and Glioma, Malignant, run by Nuvation Bio Inc. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioma, Malignant, Glioma, Mixed
- What is being tested?
- NUV-422
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 12 sitesUnited States
- Study dates
- 8 Dec 2020to 31 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For All Cohorts:
- Recovered from toxicity to prior anti-cancer therapy
- Adequate bone marrow and organ function
- Appropriate candidate for NUV-422 monotherapy
- 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.
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- High-Grade Glioma:
- Histologically confirmed diagnosis of high-grade glioma
- Evidence of recurrence after treatment (ie, surgery, radiation, or temozolomide) or refractory (or intolerant) to treatment
- Measurable or non-measurable disease
- Karnofsky Performance Status (KPS) score ≥ 60
- HR+HER2- Metastatic Breast Cancer:
- Men and women who are not suitable for surgical resection or radiotherapy for the purpose of cure
- Diagnosis of locally advanced or HR+HER2- metastatic breast cancer
- Evidence of progression as determined by the Investigator per standard criteria
- Patients must have endocrine-resistant disease
- 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
- Have no known active or symptomatic central nervous system (CNS) disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Metastatic Castration-Resistant Prostate Cancer:
- Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
- Evidence of disease progression as determined by Investigator per standard criteria
- Have no known active or symptomatic CNS disease
- Received prior therapy with anti-androgen(s) and taxane-based chemotherapy for castration-resistant disease
- ECOG PS ≤ 2
Who cannot join
- 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
- Has a history of or current use of bevacizumab (glioma and brain metastases only)
- 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
- 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
- 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
- Females who are pregnant or breast feeding
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Texas Oncology P.A. Austin
Austin, Texas, 78705
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Miami Cancer Institute
Miami, Florida, 33176
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Arizona Oncology Associates
Tucson, Arizona, 85711
Texas Oncology
Tyler, Texas, 75702
About this study
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
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.
- Conditions
- Glioma, Glioma, Malignant, Glioma, Mixed, Glial Cell Tumors, Breast Cancer, Breast Carcinoma
- Being tested
- NUV-422
- Keywords
- Phase 1, malignant glioma, metastatic breast cancer, metastatic castration-resistant prostate cancer
- Medical subject headings
- Glioma, Breast Neoplasms, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUV-422Drug
NUV-422 is an investigational drug for oral dosing.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached. Receives: Drug: NUV-422 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D)
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Measured: During the DLT period (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start8 Dec 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541225
- Sponsor's protocol ID
- NUV-422-02
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04541225
- Acronym / sponsor ID
- NUV-422-02
- Conditions
- Glioma, Glioma, Malignant, Glioma, Mixed, Glial Cell Tumors, Breast Cancer, Breast Carcinoma
- Keywords
- Phase 1, malignant glioma, metastatic breast cancer, metastatic castration-resistant prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: NUV-422NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Recovered from toxicity to prior anti-cancer therapy
- Adequate bone marrow and organ function
- Appropriate candidate for NUV-422 monotherapy
- 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.
Key exclusion criteria (6 listed)
- 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
- Has a history of or current use of bevacizumab (glioma and brain metastases only)
- 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
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUV-422NUV-422 is an investigational drug for oral dosing. | Drug | Phase 1 Dose Escalation |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NUV-422 in people with Glioma and Glioma, Malignant, run by Nuvation Bio Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.