Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03093116
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2017-03-06
Brief Title:
A Study of Repotrectinib TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK ROS1 or NTRK1-3 Rearrangements
Sponsor:
Turning Point Therapeutics Inc
Organization:
Turning Point Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Open-Label Multi-Center First-in-Human Study of the Safety Tolerability Pharmacokinetics and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK ROS1 or NTRK1-3 Rearrangements TRIDENT-1
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05926232
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
TRIDENT-1
Brief Summary:
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities DLTs the maximum tolerated dose MTD the biologically effective dose and recommended Phase 2 dose RP2D of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK ROS1 NTRK1 NTRK2 or NTRK3 gene rearrangement
Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction
Phase 2 will determine the confirmed Overall Response Rate ORR as assessed by Blinded Independent Central Review BICR of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1 NTRK1 NTRK2 or NTRK3 gene rearrangement The secondary objective will include the duration of response DOR time to response TTR progression-free survival PFS overall survival OS and clinical benefit rate CBR of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1 NTRK1 NTRK2 or NTRK3 gene rearrangement
Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction
Phase 2 will determine the confirmed Overall Response Rate ORR as assessed by Blinded Independent Central Review BICR of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1 NTRK1 NTRK2 or NTRK3 gene rearrangement The secondary objective will include the duration of response DOR time to response TTR progression-free survival PFS overall survival OS and clinical benefit rate CBR of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1 NTRK1 NTRK2 or NTRK3 gene rearrangement
Detailed Description:
In Phase 2 study subjects will be enrolled into 6 distinct expansion EXP cohorts
EXP-1 ROS1 TKI-naïve ROS1 NSCLC Up to one prior line of chemotherapy OR immunotherapy is allowed
EXP-2 1 Prior ROS1 TKI AND 1 Platinum-based Chemotherapy ROS1 NSCLC Disease progression or intolerant to one prior line of a ROS1 TKI Must have received one prior line of platinum based chemotherapy OR one prior line of platinum based chemotherapy in combination with immunotherapy before or after a ROS1 TKI
EXP-3 2 Prior ROS1 TKIs AND NO Chemotherapy ROS1 NSCLC Disease progression or intolerant to 2 prior lines of a ROS1 TKI treatment No prior lines of chemotherapy or immunotherapy are allowed
EXP-4 1 Prior ROS1 TKI and NO Chemotherapy or Immunotherapy Disease progression or intolerant to one prior line of a ROS1 TKI No prior lines of chemotherapy or immunotherapy are allowed
EXP-5 TRK TKI-naïve NTRK solid tumors Any number of prior lines of chemo or immunotherapy is allowed
EXP-6 TRK TKI-pretreated NTRK solid tumors Disease progression or intolerant to 1 or 2 prior TRK TKIs Any number of prior lines of chemo- or immunotherapy are allowed
EXP-1 ROS1 TKI-naïve ROS1 NSCLC Up to one prior line of chemotherapy OR immunotherapy is allowed
EXP-2 1 Prior ROS1 TKI AND 1 Platinum-based Chemotherapy ROS1 NSCLC Disease progression or intolerant to one prior line of a ROS1 TKI Must have received one prior line of platinum based chemotherapy OR one prior line of platinum based chemotherapy in combination with immunotherapy before or after a ROS1 TKI
EXP-3 2 Prior ROS1 TKIs AND NO Chemotherapy ROS1 NSCLC Disease progression or intolerant to 2 prior lines of a ROS1 TKI treatment No prior lines of chemotherapy or immunotherapy are allowed
EXP-4 1 Prior ROS1 TKI and NO Chemotherapy or Immunotherapy Disease progression or intolerant to one prior line of a ROS1 TKI No prior lines of chemotherapy or immunotherapy are allowed
EXP-5 TRK TKI-naïve NTRK solid tumors Any number of prior lines of chemo or immunotherapy is allowed
EXP-6 TRK TKI-pretreated NTRK solid tumors Disease progression or intolerant to 1 or 2 prior TRK TKIs Any number of prior lines of chemo- or immunotherapy are allowed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TPX-0005-01 | OTHER | Turning Point Therapeutics Protocol ID | None |
| CA127-1024 | OTHER | None | None |