Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326411
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-15
Brief Title:
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects with Solid Tumors
Sponsor:
Nested Therapeutics Inc
Organization:
Nested Therapeutics Inc
Study Overview
Official Title:
A Phase I Open Label Single-arm Two-part Study to Investigate Safety Pharmacokinetics and Preliminary Efficacy of Pan-RAFMEK Glue NST-628 Oral Tablets in Subject with Solid Tumors Harboring Genetic Alterations in the MAPK Pathway and with Other Solid Tumors
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:
NST-628
Brief Summary:
This is a two-part Phase 1 open label multi-center single arm non-randomized multiple dose safety pharmacokinetic PK and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutateddependent advanced solid tumors who have exhausted standard treatment options
Detailed Description:
The study includes two parts a dose escalation part Part A followed by a dose expansion part Part B Part A will estimate the maximum tolerated dose MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the recommended dose for expansion RDE Successive cohorts of subjects will receive escalating doses of NST-628 orally once daily in 28-day cycles
Bayesian Optimal Interval BOIN method will be used for dose escalation
Once MTD is reached or dose escalation is stopped prior to reaching MTD and provisional RDE selected the provisional RDE level will be expanded If warranted by dosetoxicityanti-tumor activity observations additional lower dose levels may also be expanded
Part B of the study will include up to 6 cohorts of approximately up to 30 subjects each with select MAPK pathway mutant solid tumors enrolled at the RDE in order to explore benefit from treatment as suggested by preclinical findings and will better define the safety profile of NST-628 at the RDE Additional safety information gathered in Part B may be used to modify the dose recommended for future studies
The end of the study is the last visit of the last subject
Bayesian Optimal Interval BOIN method will be used for dose escalation
Once MTD is reached or dose escalation is stopped prior to reaching MTD and provisional RDE selected the provisional RDE level will be expanded If warranted by dosetoxicityanti-tumor activity observations additional lower dose levels may also be expanded
Part B of the study will include up to 6 cohorts of approximately up to 30 subjects each with select MAPK pathway mutant solid tumors enrolled at the RDE in order to explore benefit from treatment as suggested by preclinical findings and will better define the safety profile of NST-628 at the RDE Additional safety information gathered in Part B may be used to modify the dose recommended for future studies
The end of the study is the last visit of the last subject
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?:
None
Is an FDA AA801 Violation?:
None