Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609005
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
A Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Antitumor Activity of INV-9956 in Adult Patients with Advanced Metastatic Castration Resistant Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Multi-Center Open-Label Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients with Advanced Metastatic Castration Resistant Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 1a first-in-human open-label dose-escalation study to determine the RDR andor MTD and to assess the DLT of INV-9956 The safety tolerability PKPD and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC
Detailed Description:
This is a Phase 1a first-in-human open-label dose-escalation study to determine the RDR andor MTD and to assess the DLT of INV-9956 The safety tolerability PKPD and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC The study will be conducted in 3 stages Stage 1 dose escalation Stage 2 dose expansion Stage 3 optional Dose escalation beyond the optimal dose
The total number of patients enrolled will depend upon the number of dose-escalation cohorts and the number of doses evaluated in Stage 2
The investigational drug will be co-administered with dexamethasone and fludrocortisone acetate as corticosteroid replacement therapy
The total number of patients enrolled will depend upon the number of dose-escalation cohorts and the number of doses evaluated in Stage 2
The investigational drug will be co-administered with dexamethasone and fludrocortisone acetate as corticosteroid replacement therapy
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