Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05641493
Status:
RECRUITING
Last Update Posted:
2023-04-10
First Post:
2022-11-15
Brief Title:
A Phase IbII Clinical Trial to Evaluate the Safety and Efficacy of HLX208HLX10 in NSCLC With BRAF V600E Mutation
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Phase IbII Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of HLX208 BRAF V600E Inhibitor Combined With SerplulimabHLX10 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 IbII clinical study to evaluate safety tolerability pharmacokinetics and efficacy of HLX208 BRAF V600E Inhibitor combined with HLX10 anti-PD-1 monoclonal antibodyin advanced NSCLC patients with BRAF V600 mutation
Detailed Description:
This is an open-label multicenter phase IbII clinical study to evaluate safety tolerability pharmacokinetics and efficacy of HLX208 BRAF V600E Inhibitor combined with HLX10 anti-PD-1 monoclonal antibodyin 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:
None
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?:
None