OncoMatch/Clinical Trials/NCT06634849
An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).
Is NCT06634849 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies PTT-4256 for advanced solid tumor.
Treatment: PTT-4256 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Participant must require systemic treatment for their tumour and either: be refractory to, have progressed on, be intolerant to, or be not otherwise a candidate - in the opinion of the Investigator - for any of the currently available standard treatments.
Cannot have received: anti-cancer therapy (including chemotherapy, immunotherapy, radiation therapy, biologic therapy, or any investigational therapy)
Exception: palliative radiotherapy within 28 days may be eligible case-by-case
Received anti-cancer therapy (including chemotherapy, immunotherapy, radiation therapy, biologic therapy, or any investigational therapy) within 28 days or 5 half-lives of the therapeutic agent, whichever is shorter, prior to the first IMP administration. Palliative radiotherapy given within 28 days prior to the first IMP administration may be considered eligible on a case-by-case basis, in discussion with the Sponsor.
Cannot have received: other investigational medicinal products
Use of other investigational medicinal products within 2 weeks or at least 5 half-lives (whichever is longer) before IMP administration.
Lab requirements
Blood counts
Haemoglobin ≥ 8.5 g/dL, ANC ≥ 1.5 × 10^9/L, Platelet count ≥ 90 x 10^9/L (no blood or platelet transfusion within 7 days prior to Screening)
Kidney function
eGFR > 30 mL/min/1.73 m2 (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5 institutional ULN (or ≤ 2 × ULN with known hepatobiliary metastases or Gilbert's syndrome); AST and ALT ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
Cardiac function
Confirmed Baseline QTcF ≤ 450 msec for males and ≤ 470 msec for females (triplicate ECG); no history of torsades de pointes or congenital long QT syndrome
Adequate haematological (blood or platelet transfusion not allowed within 7 days prior to Screening), liver, and renal function defined below (repeat measurement of borderline values permitted): Haemoglobin ≥ 8.5 g/dL, Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, Platelet count ≥ 90 x 10^9/L, Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), (or where ≤ 2 × ULN with known hepatobiliary metastases or Gilbert's syndrome), Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 2.5 × ULN (or ≤ 5 ×ULN if liver metastases are present), Estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (calculated using Cockcroft-Gault). Confirmed Baseline QTcF > 450 msec for males and > 470 msec for females (triplicate ECG) or history of torsades de pointes or history of congenital long QT syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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