Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635785
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Safety Pharmacokinetics and Efficacy of AI-081 a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Pharmacokinetics and Efficacy of AI-081 a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
BIPAVE-001 is a Phase 1-2 study for evaluating the safety pharmacokinetics PK and efficacy of AI-081 and it is consisting of two integrated parts Part A is the first-in-human dose escalation study to determine the recommended Phase 2 dose RP2D of AI-081 monotherapy while Part B are dose optimization trials comparing the safety and clinical activities of AI-081 at RP2D and one dose level lower than RP2D RP2D-1 either as monotherapy or in combination therapy with standard of care SOC in selected indications
Detailed Description:
None
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