Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634849
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Modular Open Label Dose Finding Phase 12 Clinical Trial in Patients With Solid Tumours to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of PTT-4256
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 open label dose escalation module will evaluate the safety tolerability PK PD and preliminary efficacy of PTT-4256 in participants with solid tumours using a combination of accelerated dose titration ADT and Bayesian Optimal Interval BOIN design
Detailed Description:
Module A- This module also aims to determine the MTD if reached and preliminary OBD optimal biological dose and RP2D Recommended Phase 2 dose Eligible participants will be adults with cytologically or histologically confirmed solid malignancy and locally advanced or metastatic disease who require systemic treatment for their tumour and are either refractory to have progressed on are intolerant to or are not otherwise a candidate in the opinion of the Investigator for any of the currently available standard treatments
Module A will employ an ADT design for the first 2 cohorts Cohorts A1 and A2 followed by a BOIN design for the subsequent cohorts Cohorts A3 onwards Participants will undergo a Screening period beginning up to 28 days prior to first dose and will be required to sign an informed consent form ICF before undertaking any study-specific procedures or assessments
Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled
Safety oversight will be provided by a Safety Review Committee SRC comprising the Investigators the Sponsors Medical Monitor MMrepresentatives and other independent specialists eg statistician
Module A will employ an ADT design for the first 2 cohorts Cohorts A1 and A2 followed by a BOIN design for the subsequent cohorts Cohorts A3 onwards Participants will undergo a Screening period beginning up to 28 days prior to first dose and will be required to sign an informed consent form ICF before undertaking any study-specific procedures or assessments
Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled
Safety oversight will be provided by a Safety Review Committee SRC comprising the Investigators the Sponsors Medical Monitor MMrepresentatives and other independent specialists eg statistician
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