Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04985604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2021-06-23
Brief Title:
Tovorafenib DAY101 Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors
Sponsor:
Day One Biopharmaceuticals Inc
Organization:
Day One Biopharmaceuticals Inc
Study Overview
Official Title:
A Phase 1b2 Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent Progressive or Refractory Solid Tumors Harboring MAPK Pathway Aberrations
Status:
ACTIVE_NOT_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:
None
Brief Summary:
This is a Phase 1b2 multi-center open label umbrella study of patients 12 years of age with recurrent progressive or refractory melanoma or other solid tumors with alterations in the key proteins of the RASRAFMEKERK pathway referred to as the MAPK pathway
Detailed Description:
Study DAY101-102 master study and sub-studies will consist of a screening period a treatment period a safety follow-up period and a long-term follow-up period where survival status and subsequent anticancer therapies are collected
Tovorafenib will be evaluated alone or combined with a different targeted therapy in each sub-study The Phase 1b part of each applicable sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part The Phase 2 part of each sub-study will evaluate anti-tumor activity
Substudy A will enroll patients with recurrent or progressive melanoma or other solid tumors with BRAF fusion or CRAFRAF1 fusions or amplification
Substudy B will enroll patients with recurrent or progressive melanoma or other solid tumors with alterations in the key proteins of the MAPK pathway
Tovorafenib will be evaluated alone or combined with a different targeted therapy in each sub-study The Phase 1b part of each applicable sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part The Phase 2 part of each sub-study will evaluate anti-tumor activity
Substudy A will enroll patients with recurrent or progressive melanoma or other solid tumors with BRAF fusion or CRAFRAF1 fusions or amplification
Substudy B will enroll patients with recurrent or progressive melanoma or other solid tumors with alterations in the key proteins of the MAPK pathway
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