Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536400
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-label Dose-escalation and Expansion Study to Evaluate the Safety Tolerability Pharmacokinetic and Pharmacodynamic of HSK42360 in Patients With BRAF V600 Mutation Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This is a phase I open-label dose-escalation and expansion study to evaluate the safety tolerability PK and PD of HSK42360 when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors
Detailed Description:
The study will contain two phases Phase Ia is dose escalation phase and Phase Ib is dose expansion phase
Phase Ia will contain two part Dose Escalation Part Part A and Extension Part Part B Part A based on the 33 design for dose escalation and safety evaluation requirements Patient cohorts at selected doses may be extended to further investigate the tolerability PK and PD of HSK42360 The number of patients to be enrolled will be up to 10 subjects in each Part B cohort Approximately 30-70 subjects will be enrolled in Phase Ia
Phase Ib no less than 10-50 subjects will be enrolled in each expansion cohort
Phase Ia will contain two part Dose Escalation Part Part A and Extension Part Part B Part A based on the 33 design for dose escalation and safety evaluation requirements Patient cohorts at selected doses may be extended to further investigate the tolerability PK and PD of HSK42360 The number of patients to be enrolled will be up to 10 subjects in each Part B cohort Approximately 30-70 subjects will be enrolled in Phase Ia
Phase Ib no less than 10-50 subjects will be enrolled in each expansion cohort
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