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

ClinicalTrials.gov ID: NCT04541225

Public ClinicalTrials.gov record NCT04541225. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT04541225
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Nuvation Bio Inc.; Industry
Enrollment: 74 participants

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 7, 2020
Primary completion: Aug 30, 2022
Completion: Aug 30, 2022
Last update posted: Jul 13, 2023

2020 – 2022

United States locations

U.S. sites: 12
U.S. states: 9
U.S. cities: 12

Facility	City	State	ZIP	Site status
Arizona Oncology Associates	Tucson	Arizona	85711	—
Miami Cancer Institute	Miami	Florida	33176	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
Carolina BioOncology Institute	Huntersville	North Carolina	28078	—
Prisma Health Cancer Institute	Greenville	South Carolina	29605	—
Texas Oncology P.A. Austin	Austin	Texas	78705	—
Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas	75246	—
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	—
Texas Oncology	Tyler	Texas	75702	—
University of Utah Huntsman Cancer Institute	Salt Lake City	Utah	84112	—
Virginia Cancer Specialists	Fairfax	Virginia	22031	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04541225, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 13, 2023 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04541225 live on ClinicalTrials.gov.

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