Actively Recruiting
An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).
Led by Pathios Therapeutics Pty Ltd · Updated on 2026-02-10
30
Participants Needed
5
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of consent
- Written informed consent provided and ability to follow study protocol
- Cytologically or histologically confirmed solid malignancy with locally advanced or metastatic disease
- Requires systemic treatment and is refractory to, progressed on, intolerant to, or not a candidate for standard treatments
- Measurable disease per RECIST v1.1 or considered eligible if non-measurable with Sponsor discussion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Estimated life expectancy of at least 3 months
- Adequate hematological, liver, and renal function as defined by specified laboratory values
- Females must not be pregnant or lactating and must use effective contraception or be abstinent; negative pregnancy tests required for women of childbearing potential
- Females of non-childbearing potential must be postmenopausal for at least 12 months or aged 60 or older
- Males must be surgically sterile or use effective contraception if sexually active with women of childbearing potential
- Males must not donate sperm from first dose until 90 days after last dose
You will not qualify if you...
- Unable or unwilling to adhere to study procedures and oral medication intake
- Active primary CNS malignancy, active CNS metastases, or leptomeningeal disease unless stable and controlled
- Unresolved serious toxic side effects from prior chemotherapy or radiotherapy (grade 2 or higher) within 6 weeks
- History of other malignancies within 2 years except certain treated cancers with no active disease
- Received anti-cancer therapy within 28 days or 5 half-lives prior to first dose
- Uncontrolled or recurrent malignant effusions
- Clinically significant active autoimmune or chronic inflammatory disease not well controlled
- Grade 3 or higher immunotherapy-induced autoimmune hepatitis
- Recent symptomatic colitis or history of severe autoimmune or drug-induced colitis
- History of primary immunodeficiency or organ transplantation
- Use of systemic immunosuppressive medication above specified levels within 14 days
- Active hepatitis B or C infection, or active HIV infection
- Active infection requiring systemic therapy within 7 days
- Clinically significant cardiovascular disease or events within 4 months
- Baseline prolonged QT interval or history of specific heart rhythm disorders
- History of significant lung disease or conditions interfering with pulmonary toxicity assessment
- Major surgery within 28 days prior to first dose
- Other severe uncontrolled medical, psychiatric, or social conditions affecting safety or participation
- Use of other investigational drugs within 2 weeks or 5 half-lives
- Live vaccine administration within 28 days prior to first dose
- Known active or suspected substance abuse interfering with study
- Gastrointestinal conditions affecting oral drug absorption as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
2
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
3
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide, South Australia, Australia, 5042
Actively Recruiting
4
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
5
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
D
Debbie Macaro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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