Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02797795
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1, Open-Label, Dose-Escalation Study of NEV801, Administered to Patients With Advanced Cancers
Sponsor:
Neovia Oncology Ltd.
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered NEV801 in Subjects With Advanced Malignancies
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial to be conducted in 2 sequential parts:
* Part A (Dose Escalation) in subjects with advanced malignancies
* Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of Part A
* Part A (Dose Escalation) in subjects with advanced malignancies
* Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of Part A
Detailed Description:
In Part A, subjects will be treated with a 30-minute intravenous (IV) infusion of NEV801 on Days 1, 8, 15, and 22 of continuous 28-day cycles. The starting dose of NEV801 will be 20 mg/m2/dose, and the NEV801 dose will be escalated in successive cohorts of 3 subjects per dose level. In Part B, up to 3 expansion cohorts of up to 12 subjects each, defined by tumor type, will be enrolled at or below the MTD (i.e., the RP2D) of NEV801. In both parts, subjects who tolerate the drug and who do not experience progressive disease may continue to receive NEV801 at the discretion of the Investigator for up to 12 cycles. Subjects who tolerate the drug and experience clinical benefit will be eligible for further treatment in an extension protocol or through another means to be determined by the Sponsor.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: