NCT06634849 An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).
| NCT ID | NCT06634849 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Pathios Therapeutics Pty Ltd |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2027-04-30 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age at the time of consent. 2. Participant has given written informed consent to participate in the study and is able and willing to adhere to the study protocol. 3. Participant has cytologically or histologically confirmed solid malignancy and has locally advanced or metastatic disease. Melanoma, non-small cell lung cancer, renal cell carcinoma, metastatic castrate-resistant prostate cancer, cervix cancer, triple negative breast cancer, colorectal cancer, gastric cancer are preferred solid tumours. 4. Participant must require systemic treatment for their tumour and either: 1. be refractory to, 2. have progressed on, 3. be intolerant to, or 4. be not otherwise a candidate - in the opinion of the Investigator - for any of the currently available standard treatments. 5. Participant has measurable disease per RECIST v1.1. Participants with non-measurable disease per RECIST v1.1 might be considered eligible upon discussion with the Sponsor. 6. Participa