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An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours.
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.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-21
Primary completion: 2027-04-30
Study completion finish: 2027-10-30
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06634849
Intervention or treatment
DRUG: PTT-4256
Conditions
- • Advanced Solid Tumor
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: PTT-4256
| DRUG: PTT-4256
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with Treatment emergent adverse events (TEAEs), Adverse events and Serious Adverse events as assessed by CTCAE V5.0 | Not Specified | First dose IMP to 21 to 28 days after last IMP dose. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To determine the maximum tolerated dose (MTD) | Determined by dose limiting toxicities (DLT) occurring in 21 days following initiation of once daily administration | Baseline to 21 to 28 days after last IMP dose. |
To determine OBD | Determined by dose limiting toxicities (DLT) occurring in 21 days following initiation of once daily administration and by SRC (safety review committee) | Baseline to 21 to 28 days after last IMP dose. |
To determine R2PD | Determined by dose limiting toxicities (DLT) occurring in 21 days following initiation of once daily administration and by SRC (safety review committee) | Baseline to 21 to 28 days after last IMP dose. |
Plasma pharmacokinetics at single dose- Maximum observed concentration (Cmax) | Not Specified | Pre-dose, 2hours, 4hours, 8hours, and 12 hours Day 1, then at 24hours (Day2), 48 hours (Day 3) and 72 hours (Day4) |
Plasma pharmacokinetics at single dose- Time to maximum concentration (Tmax) | Not Specified | Pre-dose, 2hours, 4hours, 8hours, and 12 hours Day 1, then at 24hours (Day2), 48 hours (Day 3) and 72 hours (Day4) |
Plasma pharmacokinetics at single dose- Area under the drug concentration-time curve, from time zero extrapolated to infinity (AUC0-last) | Not Specified | Pre-dose, 2hours, 4hours, 8hours, and 12 hours Day 1, then at 24hours (Day2), 48 hours (Day 3) and 72 hours (Day4) |
Plasma pharmacokinetics at single dose- Area under curve from zero to 24hrs (AUC0-24) | Not Specified | Pre-dose, 2hours, 4hours, 8hours, and 12 hours Day 1, then at 24hours (Day2), 48 hours (Day 3) and 72 hours (Day4) |
Plasma pharmacokinetics at single dose- Apparent terminal half-life (t1/2) | Not Specified | Pre-dose, 2hours, 4hours, 8hours, and 12 hours Day 1, then at 24hours (Day2), 48 hours (Day 3) and 72 hours (Day4) |
Plasma PK at steady state- Maximum observed concentration in the dosing interval at steady state (Cmax,ss) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Minimum observed concentration in the dosing interval at steady state (Cmin,ss) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Average steady state concentration (Cavg,ss) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- e to maximum observed plasma analyte concentration at steady state (Tmax,ss) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Time to minimum concentration at steady state (Tmin,ss) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Areas under the drug concentration-time curve over a dosing interval using the 'the linear up and log down' method (AUC0-tau) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Swing | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Fluctuation | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- Trough concentration (Ctrough) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- accumulation ratios (RA) of Cmax | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
Plasma PK at steady state- accumulation ratios (RA) of Area under curve (AUC) | Not Specified | Baseline to Cycle 2 Day 2 - 22 days |
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