Oral Paclitaxel for Patients with Advanced Solid Tumors
Status:
RECRUITING
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
Phase I trial evaluating the safety, tolerability, and pharmacokinetic profile of INP12, a nanoparticles-based oral paclitaxel, in patients with advanced solid tumors
The aim in Part A (Escalation phase) is to determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD)and the recommended phase II dose (RP2D) of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors.
The aim in Part B (Expansion phase) is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors.