Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT05641493
Status:
RECRUITING
Last Update Posted:
2023-04-10
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX208 （BRAF V600E Inhibitor） Combined With Serplulimab（HLX10, Anti-PD-1 Antibody） in Advanced NSCLC Patients With BRAF V600E Mutation.
Status:
RECRUITING
Status Verified Date:
2023-04
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:
An open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation.
Detailed Description:
This is an open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation.
For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: