Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190886
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-19
Brief Title:
A First-in-human FIH Multicenter Open-Label Phase I Study of PTX-912 in Patients With Locally AdvancedMetastatic Solid Tumors
Sponsor:
Proviva Therapeutics Inc
Organization:
Proviva Therapeutics Inc
Study Overview
Official Title:
A First-in-human FIH Multicenter Open-Label Phase Ia Dose EscalationPhase Ib Dose Expansion Study of PTX-912 in Patients With Locally AdvancedMetastatic Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors To evaluate the PK and immunogenicity profile of PTX-912 To evaluate the preliminary anti-tumor activity of PTX-912
Participants will be treated with PTX-912 via iv infusion every 2 weeks until progression of disease unacceptable toxicity or 12 months of total study therapy
Participants will be treated with PTX-912 via iv infusion every 2 weeks until progression of disease unacceptable toxicity or 12 months of total study therapy
Detailed Description:
None
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