Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270082
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-31
Brief Title:
Study of IK-595 in RAS- or RAF-altered Advanced Tumors
Sponsor:
Ikena Oncology
Organization:
Ikena Oncology
Study Overview
Official Title:
A First-in-Human FiH Study of IK-595 an Oral Dual MEKRAF Inhibitor in Patients With RAS-or RAF-altered Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a Phase 1 FIH Dose Escalation and Dose Expansion study to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD effects and preliminary antitumor activity of IK-595 a MEKRAF molecular glue administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit
Detailed Description:
This is a Phase 1 FiH clinical study to evaluate the safety tolerability PK and pharmacodynamic effects and preliminary anti-tumor activity of IK-595 a dual mitogen-activated protein kinase kinase MEK RAF kinase inhibitor administered orally PO as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit
The study consists of an initial Dose Escalation phase using a Bayesian Optimal Interval BOIN design followed by a Dose Expansion phase in 4 geneticallymolecularly defined cohorts using 2-stage adaptive design
During the Dose Escalation phase backfilling may occur where 3 additional patients can be enrolled at a given dose level once that dose level is deemed safe and tolerable by the Safety Review Committee Backfilling includes but is not limited to patients with the following diagnoses neuroblastoma RAS viral oncogene homolog-mutant NRASmut colorectal carcinoma CRC NRASmut malignant melanoma Kirsten rat sarcoma viral oncogene homolog-mutant KRASmut CRC KRASmut pancreatic cancer KRASmut non-small cell lung cancerNSCLC B-Raf proto-oncogene serinethreonine kinase-mutant BRAFmut Class IIIII or BRAF fusion positive solid tumors and Raf-1 proto-oncogene serinethreonine kinase-mutant CRAFmut or fusion positive solid tumors
Various dose levels and schedules will be explored
The study consists of an initial Dose Escalation phase using a Bayesian Optimal Interval BOIN design followed by a Dose Expansion phase in 4 geneticallymolecularly defined cohorts using 2-stage adaptive design
During the Dose Escalation phase backfilling may occur where 3 additional patients can be enrolled at a given dose level once that dose level is deemed safe and tolerable by the Safety Review Committee Backfilling includes but is not limited to patients with the following diagnoses neuroblastoma RAS viral oncogene homolog-mutant NRASmut colorectal carcinoma CRC NRASmut malignant melanoma Kirsten rat sarcoma viral oncogene homolog-mutant KRASmut CRC KRASmut pancreatic cancer KRASmut non-small cell lung cancerNSCLC B-Raf proto-oncogene serinethreonine kinase-mutant BRAFmut Class IIIII or BRAF fusion positive solid tumors and Raf-1 proto-oncogene serinethreonine kinase-mutant CRAFmut or fusion positive solid tumors
Various dose levels and schedules will be explored
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