Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521554
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC HEROEX-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1a1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC HEROEX-1
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1a1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330 determine the recommended Phase 2 dose RP2D and evaluate the antitumor activity in patients with advanced or metastatic HER2-altered NSCLC
Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2Ds and if applicable the MTD
Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2Ds of NVL-330 and to determine the RP2D of NVL 330 in patients with advanced or metastatic HER2 mutant NSCLC
Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2Ds and if applicable the MTD
Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2Ds of NVL-330 and to determine the RP2D of NVL 330 in patients with advanced or metastatic HER2 mutant NSCLC
Detailed Description:
The planned Phase 1a1b first-in-human study is designed as a two-part clinical trial to investigate NVL-330 in pre-treated patients with advanced or metastatic HER2-altered NSCLC The dose escalation phase of the trial is designed to enroll a set number of patients per cohort at protocol defined dose levels After the initial patients are treated at a given dose level and monitored for at least 28 days available data will be reviewed and initiation of the next dosing group will proceed with consideration given to the overall safety profile
The expansion phase of the trial is designed to further evaluate safety and activity and to confirm the RP2Ds
The expansion phase of the trial is designed to further evaluate safety and activity and to confirm the RP2Ds
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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?:
None