Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04541225|
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Glioma Glioma, Malignant Glioma, Mixed Glial Cell Tumors||Drug: NUV-422||Phase 1 Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas|
|Actual Study Start Date :||December 8, 2020|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Phase 1 Dose Escalation
NUV-422 administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
Experimental: Phase 2 Dose Expansion
NUV-422 administered at the recommended Phase 2 dose (RP2D).
- Phase 1 Dose Escalation [ Time Frame: During the dose-limiting toxicity (DLT) period (28 days) ]Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
- Phase 2 Dose Expansion: Cohort 1 [ Time Frame: Every 8 weeks through study treatment, an average of 6 months ]Objective response rate (ORR)
- Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]Evaluation of NUV-422 concentration in plasma, including peak plasma concentration (Cmax).
- Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]Evaluation of NUV-422 half-life in plasma.
- Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]Evaluation of NUV-422 concentration in brain tumor tissue.
- Phase 2 Dose Expansion: Cohort 2 [ Time Frame: Intraoperatively after 21 days of study treatment ]Evaluation of NUV-422 effects on brain tumor cell proliferation ratio pre and post-treatment.
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
|Contact: Clinical Trials at Nuvation Bio||332-208-6102||ClinicalTrials@nuvationbio.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Patrick Y Wen, MD 617-632-2166|
|Contact: Rachel Fox 617-632-6668|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Thomas Kaley, MD 212-639-5122|
|Contact: Christine Jarjies 646-907-2567|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jordi Rodon, MD, PhD 713-563-1930|
|United States, Utah|
|University of Utah Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Howard Colman, MD 801-585-0255 Howard.Colman@hci.utah.edu|
|Contact: Sara Woltz 801-585-0431 Sara.Woltz@hci.utah.edu|