NCT06634849

An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).

A Modular, Open Label, Dose Finding, Phase 1/2 Clinical Trial in Patients With Solid Tumours to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PTT-4256.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pathios Therapeutics Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Sponsor's Medical Monitor (MM)/representatives and other independent specialists (e.g. statistician).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	PTT-4256	Single oral intake of PTT-4256 followed by treatment-free period of 3 days to assess safety, PK and PD. After 72-hr post dose PK sample, first 21day cycle of once daily PTT-4256 will begin to assess DLTs. Cohorts A1-A5 will receive 10mg, 20mg, 40mg, 80mg \& 160mg. Following review by SRC, Cohort A6 participants will receive 300mg PTT-4256 daily.

Timeline

• Start date: 2024-11-04
• Primary completion: 2027-04-30
• Completion: 2027-10-30
• First posted: 2024-10-10
• Last updated: 2026-02-10

Locations

5 sites across 1 country: Australia