Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05384626
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2022-05-17
Brief Title:
A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation ALKOVE-1
Sponsor:
Nuvalent Inc
Organization:
Nuvalent Inc
Study Overview
Official Title:
A Phase 12 Study of the Selective Anaplastic Lymphoma Kinase ALK Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors ALKOVE-1
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Phase 12 dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655 determine the recommended phase 2 dose RP2D and evaluate the antitumor activity in patients with advanced ALK- positive ALK NSCLC and other solid tumors
Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and if applicable the MTD of NVL-655 in patients with advanced ALK solid tumors
Phase 2 will determine the objective response rate ORR as assessed by Blinded Independent Central Review BICR of NVL-655 at the RP2D Secondary objectives will include the duration of response DOR time to response TTR progression-free survival PFS overall survival OS and clinical benefit rate CBR of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors
Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and if applicable the MTD of NVL-655 in patients with advanced ALK solid tumors
Phase 2 will determine the objective response rate ORR as assessed by Blinded Independent Central Review BICR of NVL-655 at the RP2D Secondary objectives will include the duration of response DOR time to response TTR progression-free survival PFS overall survival OS and clinical benefit rate CBR of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors
Detailed Description:
In Phase 2 study patients will be enrolled into 6 distinct cohorts
Cohort 2a Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI ceritinib alectinib or brigatinib Up to 2 prior lines of chemotherapy andor immunotherapy are allowed
Cohort 2b Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 2-3 prior ALK TKIs crizotinib ceritinib alectinib brigatinib or lorlatinib Up to 2 prior lines of chemotherapy andor immunotherapy are allowed
Cohort 2c Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received lorlatinib as the only prior ALK TKI therapy Up to one prior line of chemotherapy andor immunotherapy received prior to lorlatinib is allowed
Cohort 2d Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who are naïve to ALK TKI therapy Up to one prior line of chemotherapy andor immunotherapy is allowed
Cohort 2e Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement not eligible for other Phase 2 cohorts
Cohort 2f Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation who have received 1 prior systemic anticancer therapy or for whom no satisfactory standard therapy exists
Cohort 2a Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI ceritinib alectinib or brigatinib Up to 2 prior lines of chemotherapy andor immunotherapy are allowed
Cohort 2b Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 2-3 prior ALK TKIs crizotinib ceritinib alectinib brigatinib or lorlatinib Up to 2 prior lines of chemotherapy andor immunotherapy are allowed
Cohort 2c Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received lorlatinib as the only prior ALK TKI therapy Up to one prior line of chemotherapy andor immunotherapy received prior to lorlatinib is allowed
Cohort 2d Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who are naïve to ALK TKI therapy Up to one prior line of chemotherapy andor immunotherapy is allowed
Cohort 2e Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement not eligible for other Phase 2 cohorts
Cohort 2f Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation who have received 1 prior systemic anticancer therapy or for whom no satisfactory standard therapy exists
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