Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05226507
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2022-01-13
Brief Title:
A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
Sponsor:
Nuvectis Pharma Inc
Organization:
Nuvectis Pharma Inc
Study Overview
Official Title:
A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800 In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated
Detailed Description:
Part A of the study is a dose escalation by cohort study of NXP800 administered to patients with advanced cancers The study will identify the maximum tolerated dose MTD and propose dose and dose schedules for future studies
In Part B doses selected in Part A are administered to patients with platinum-resistant ARID1a-mutated ovarian carcinoma
In Part B doses selected in Part A are administered to patients with platinum-resistant ARID1a-mutated ovarian carcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ENGOT-GYN5NCRINXP800-101 | OTHER | None | None |
| GOG-3087 | OTHER | GOG Foundation | None |