Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05971862
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-06-29
Brief Title:
A Study to Evaluate the Safety Tolerability and Pharmacokinetics of SKI-G-801 in Patients With Advanced Solid Tumors
Sponsor:
Oscotec Inc
Organization:
Oscotec Inc
Study Overview
Official Title:
An Open-label Multi-center Dose-escalation and Dose-finding Phase I Study to Evaluate the Safety Tolerability and Pharmacokinetics of SKI- G-801 as Monotherapy in Patients With Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by assessing the safety and tolerability including dose-limiting toxicity DLT at various dose levels and to explore the efficacy and PK in patients with advanced solid tumors
Detailed Description:
This is an open-label monotherapy study in patients with advanced solid tumors to evaluate the safety tolerability and pharmacokinetics PK of multiple ascending doses of SKI-O-801Denfivontinib A total of 36 subjects are planned to participate in 6 cohorts traditional 33 design In each cohort 3 subjects will receive SKI-O-801 Dosing will be initiated with a 100 mg once daily QD dose cohort and escalated to 500 mg QD After 1 cycle 28 days of treatment if 3 subjects in each cohort have no DLTDose Limiting Toxicity escalate the next dose level by Safety Review Committee decision
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